approved prescription drug products

38
CUMULATI\ i. SUPPLEMENT 2 AUGUST i982 APPROVED PRESCRIPTION DRUG PRODUCTS WITH THERAPEU"nC EQUIVALENCE EVALUADONS 2ND EDITION U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES . PUI3L1C HEALTH SERVICE FOOD AND DRUG ADMINiSTRATION I3UREAU OF DRUGS

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Page 1: APPROVED PRESCRIPTION DRUG PRODUCTS

CUMULATI\ i. SUPPLEMENT ~ 2

AUGUST i982

APPROVED PRESCRIPTION DRUG PRODUCTS

WITH THERAPEU"nC EQUIVALENCE EVALUADONS

2ND EDITION

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES . PUI3L1C HEALTH SERVICE

FOOD AND DRUG ADMINiSTRATION I3UREAU OF DRUGS

Page 2: APPROVED PRESCRIPTION DRUG PRODUCTS

T - ~

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FOOD AND DRUG ADMINISTRATION APPROVED PRESCRIPTION DRUG PRODUCTS

WITH THERAPEUTIC EQUIVALENCE EVALUATIONS

CUMULATIVE SUPPLEMENT

I. PREFACE

This cumulative supplement is one of a series of monthly updates to the Approved Prescription Drug Products with Therapeutic Equivalence Evaluations, 2nd Edition, (the List) to cover interim revisions to the annual publication of the List in its entirety. The List is comprised of several parts and some

,by their nature are identified by the term "list". The cumulative supplements routinely provide updates to two of these lists: The Drug Product List and the Addendum: DESI Pending List.

The List cannot be used effectively without the current cumulative supplement. Users may wish to place an asterlsk (*) in the List to the left of the ingredient(s) in the Drug Product List and the product name in the Addendum to indicate that changes to that entry appear in the cumulative supplement. It is also suggested that earlier cumulative supplements be discarded to avoid possible confusion. In this way, only the List and current cumulative supplement need be referenced.

A. DRUG PRODUCT LIST

The Drug Product List cumulative supplements include the changes made since August 1, 1981. Each subsequent cumulative supplement replaces the previous month's cumulative supplement.

Information in this cumulative supplement follows the format of the Drug Product List. The presence of any therapeutic equivalence code indicates that the drug product is multisource; the deletion of a therapeutic equivalence code indicates that the drug product has become single source. (An infrequent exception exists when a therapeutic equivalence code is revised. In that case the deletion of the therapeutic equivalence code is followed immediately by the addition of the revised one.)

Context information on drug products is provided in each cumulative supplement for completeness to assist in locating the proper place in the Drug Product List for the revision. A page number in parentheses referring to the Drug Product List is located to the right of the ingredient(s).

Additions to the Drug Product List are indicated by new information in the cumulative supplement. Additions new to the current cumulative supplement are i nd i cated by the symbo 1 > -.A.Q!L> to the 1 eft of the 1 i ne on wh i ch new information exists. The >--A!2!L> symbol is dropped in subsequent cumulative supplements for that item.

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Deletions from the Drug Product List are indicated by overstruck print in the cumulative supplement. Deletions new to the current clDTlUlative supplement are indicated by the symbol > DLT > (DELETE) to the left of the line containing the overstruck print. 'lhe >J!..!.L> symbol is dropped in subsequent currulative supplements for that item.

A newly apprO'Ved product is identified by the lozenge (.) to the right of its strength. This identifier remains throughout all currulative supplements for this ed ition.

B. Ad.1endum:, DFSI PENDING LIST

Inforrration in this cumulative supplanent follows the format of the Mdendum. Mditions and deletions are indicated in the same manner as in the cumulative supplement to the Drug Prcrluct List. A change in Current Status of a DFSI product is also indicated by an addition and a deletion.

II. SPEI:IAL NarES

A. The INI'RODUCl'ION to the 2nd B:lition (1981 publication) of the Approved Prescription Drug Products with Therapeutic Equivalence Evaluations (Section ILF.S.) stated that "Protein hydrolysate injections are omitted because of safety problems." The safety problems have been resolved. PJblication on this subject appeared in the FEDERAL ROOISTER of July 14, 1981 (46 FR 36249). Therefore, a parenteral protein hydrolysate (!:Ee lImigen) now is approved and marketed as well as the existing related parenteral amino acid mixture solutions.

B. FUROSEMIDE 'lbe change in the therapeutic equivalence code for Cord Laboratories' Furosemide tablets from BX to AB reflects receipt of additional data from the firm; examination ofother information on file with the Agency; and a determination that the initial bioequivalence study performed by the firm was satisfactory for demonstrating prcrluct bioequivalence so that a subsequent additional study was not necessary.

C. METHOXSALEN CAPSULES 'lhe therapeutic equivalence code for Methoxsalen capsules, lOmg, manufactured by Cord Laboratories and Elder Fharmacroticals has been changed from AA to BP. A report in the literature has identified bioinequivalence between different brands of methoxsalen capsule products. On this basis the J\gency believes studies are necessary to danonstrate product bioequiva1ence before an evaluation of theraPeutic equivalence can be made.

D. APPENDICES: ROUTES OF ADMINISTRATION

Added terms: PERFUSION, CARDIAC INTRAPERITONEAL

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Page 5: APPROVED PRESCRIPTION DRUG PRODUCTS

Former Applicant (Name)

CIS RADIOPHAR~~CEUTICALS INC D-M PHARMACEUTICALS INC DOME LABORATORIES DIV

MILES LABORATORIES INC LEMMON PHARMACAL COMPANY PHILIPS ROXANE LABORATORIES INC UNION CARBIDE CORPORATION

APPLICANT (NAME) CHANGES

New Applicant (Name)

SYNCOR INTL CORPORATION LH1MON COMPANY MILES PHARMACEUTICALS DIV

MILES LABORATORIES INC LEMt~ON CQt,1P ANY ROXANE LABORATORIES INC C I NTICHEM INC

New Abbreviated Name

SYNCOR INTL LEMMON

MI LES PHARHS/~lI LE S LEMMON ROXANE LABORATORIES CINTICHEt1

The reader should consult this special list each month to become aware of such transfers and changes. By referring to the Applicant Index in the 2nd Edition, the transferred products can be identified. The reader might wish to flag these products in the List as a reminder that the applicant has been changed.

iii

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•.

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APPROVED PRESCRIPTION DRUG PRODUCTS DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT NUMBER 12 I AUGUST '81 - AUGUST '82

ACETAMINOPHEN; CODEINE PHOSPHATE (PAGE 1)

AA

AA

AA AA

1M! AA

AA AA

CAPSULE; ORAL TYLENOL WI CODEINE NO. 3

MCNEIL PHARM 300MGi30MGU TYLENOL WI CODEINE NO. 4

MCNEIL PHARM 300MGi60MGu

ELIXIR; ORAL ACETAMINOPHEH WI CODEINE

PHARMS ASSOC/BEACH 120MG/SML;12MG/SMLU

TABLET; ORAL ACETAMZNOPHEH WI CODEINE

BARR LABORATORIES 30CMG;lSMG * ~;~ * 300MG;6CMGU ACETAMINOPHEN WI COnEINE PHOSPHATE

CHELSEA LABORATORIES 300HG;15HGU * 300MG;30MGn * 3001-lG;60MGn

/'I-.':i:ptt!.#r1P.f,tJJjjf,fitl ~llI.~ij~~/: 325M!;; 30MG 'f: 325Mch 6 oHGI

KV PHARMACEUTICAL ~;15NG * ~;30MG * 300MG;6CHG 325MG;45MG

VITARINE/WEST CHEM 300MG;30HGU WESTERN RES LABS ~;30MGU * ~;60MGU

ACETAMINOPHEN; HYDROCODONE BITARTRATE (PAGE 2)

CAPSULE; ORAL LORCET-HD

DM GRAHAM LABS

TABLET; ORAL

500MG;5MGU

ACETAMINOPHEH ANn HYDROCOOONE BITARTRATE AA CENTRAL PHARMS ~;5MG~

AA DM GRAHAM LABS ~;5MGn HYCODAPHEH

AA BF ASCHER SOCMG;SHGn VICODIN

AA KNOLL PHARMACEUTICAL ~;SMG

ACETAZOLAMIDE (PAGE 2)

TABLET; ORAL ACETAZOLAMI1lE

AB VANGARD LABS/MWM 250HG~

ACETIC ACID, GLACIAL (PAGE 2)

I ~~~~~j~~S~~~~~:?~3~~~tl.' pf-#fjf,.' f,ptlf ;:;ttltM I j.~~pff.' f .. fi:~pF.fi.fpp.1.t~1 / .2~.dtlS;);i.d.citltl

SOLUTION; IRRIGATION, URETHERAL ACETIC ACID O.2S? IN PLASTZC COHTA!HF"'"

AT TRAVENOL LABS 2S(!BG/100HLn

SO LUTION; OTIC ACETASOL

AT NATL PHARM MFG/BARRE 2?n

ACETIC ACID, GL.4CIAq HYDROCORTISONE (PAGE 3)

SOLUTION; OTIC ACF.TP.SOL He

AT NATL PHARM MFG/BARRE 2?;1?U

ACYCLOVIR (PAGE 4)

OINTMENT; TOPICAL ZOVIRAX

BURROUGHS WELLCOME 5Xu

ALBUTEROL SULFATE (PAGE 4)

TABLET; ORAL PROVENTIL

1

SCHERING EQ 2MG BASEu * EQ 4MG BASEn

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE (PAGE 2)

TABLET; ORAL OXYCODOHE HCL AND ACETAHINOPMEN

AA BARR LABORATORIES 325MG;SMGU

ALCOHOL; DEXTROSE (PAGE 4)

INJECTABLE; INJECTION I A,L¢prtPf-. 'i.df-. 'ANP. 'ptx:f#Mt. '~f-. '1.)4. 'pJS.l'1..Lf-tP. "A~ftR/ ALCO~OL 10% AND DEXTROSE 5%

I UClHd( '5%; 'r:itx7t:!d5~ '5% ':rH 'distillED '!~ATERI ALC~~OL 5? AND D~Xi~05E 5?

Page 8: APPROVED PRESCRIPTION DRUG PRODUCTS

> ADO> > ADO > >...MliL> >...MliL>

DRUG PRODUCT LIST / CUMULATIVE SUPPLEMENT NUMBER 12 / AUGUST '81 - AUGUST '82 2

ALPRAZOLAM (PAGE 4)

TABLET; ORAL XANAX

UPJOHN

ALPROSTADIL (PAGE 4)

INJECTABLE; INJECTION PROSTIN VR PEDIATRIC

0.25MGa * 0.5MGa * IMGa

UPJOHN O.5MG/MLa

AMCINONIDE (PAGE 5)

OINTMENT; TOPICAL CYCLOCORT

LEDERLE LABS/AM CYAN O.l%a

AMILORIDE HYDROCHLORIDE (PAGE 5)

TABLET; ORAL MIDAMOR

MS&D/MERCK 5MGa

AMILORIDE HYDROCHLORIDEi HYDROCHLOROTHIAZIDE (PAGE 5)

TABLET; ORAL MODURETIC 5/50

MS&D/MERCK

AMINO ACIDS (PAGE 5)

INJECTABLE; INJECTION AMINOSYN 3.5:1.

5MG;50MGa

ABBOTT LABORATORIES 3.5:1.a NOVAMINE 8.5X

CUTTER LABORATORIES 8.5za NOVAMINE l1.4X

CUTTER LABORATORIES 11.4xa

AMINO ACIDS; CALCIUM ACETATE; GLYCERIN; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE (PAGE 5)

INJECTABLE; INJECTION PERIPHRAMINE

AM MCGAW/AM HOSP 3X;26MG/IOOML;3GM/IOOML;54MG/IOOML; 4IMG/IOOMl; 149HG/IOOML; 204MG/IOOML; 117MG/IOOMLIX

AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM ACETATE; SODIUM CHLORIDE (PAGE 5)

INJECTABLE; INJECTION AMINOSYN 3.5i: M

ABBOTT LABORATORIES 3.5%;21MG/IOOML;40MG/IOOMLi 128MG/IOOMLi234MG/IOOHL~

AMINO ACIDS; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDE (PAGE 5)

INJECTABLE; INJECTION / Ati.tNP~,YtV

AMINOSYN 3.5% M

AMINOPHYLLINE (PAGE 6)

ENEMA; RECTAL SOMOPHYLLIN

FISONS

INJECTABLE; INJECTION AMIH~PHYlLrH IHJECT~OH

300MG/5ML~

AP SEARLE PHARMS ~~G/MLa

AM~"OPHY'_LIHE AP ABBOTT LABORATORIES ~?MG/Ml~ AP BRISTOL LABS/B-M 25WYMll! AP INTl MEDICATION SYS 2t'r'lG/Hl!:t AP INVENEX LABS/DEXTER 25MGiML~

AP LYPHO-MED 2SMG/MLK

LIQUID; ORAL A~IIH~!'!"fYLL:rNl:: DYE FREE

AA NATL PHARM MFG/BARRE lC~HS/SMLa

TABLET; ORAL AM!H~l!liYI.L!.H

/r,p/ J .siMU, 'PHARf1.s/ AB SEARLE PHARMS

AM:rn!'l~HYlL:r.tIE

/;i.o,otl~,· f:: t,o,o;-10/ lOOMS * 200H9

BD ASCOT HOSP PHARMS IOOMG!:t * 200MG~ /~PRP, 't.f;f,PR/:fPRf.t.s1 /.9.7,:tf:$5, 'f:.';(9;+':,4tl$5/

BD CORD LABORATORIES 100MG * 200~IG BD ROXANE LA80RATORIES 100MG~ * 200NG~

/r,p/ /.sf.AN,L.Ar,.sIMtlp.A'I.J it.d.OtlM BD PUREPAC/KALIPHARM IOOMG * 200MG

/r,p/ /~~M,':'H.ARP/ fj.,d,6tl~.'f:.'t,d,dtlM AB WEST-WARD lOOMG * 200M~

Page 9: APPROVED PRESCRIPTION DRUG PRODUCTS

DRUG PRODUCT LIST / CUMULATIVE SUPPLEMENT NUMBER 12 / AUGUST '81 - AUGUST '82 3

> DLT > >...Q!L> >...Q!L> >~> >~> >~>

> DLT > >...Q!L> >...Q!L> >~> >~> >~>

AMITRIPTYLINE HYDROCHLORIDE (PAGE 7)

TABLET; ORAL

~~~~/fi~~~~gl~Pfiyj$1 jj,ot\¢. 'f. '~~tl¢.'f. '~.OJ1¢. 'f.'.7~tl¢.'f.';ip.otl¢. 'f! 1;i~.6tlM

AMURU AB PARKE-DAVIS 10MG * 25MG * 50MG * 75MG * lOCHG *

150MG AB

BP AB AB AB AB AB AB

AMXTR%PTYLrHE HeL HALSEY DRUG 10MG * 25MG * 50MGU LEDERLE LABS/AM CYAN lOMS * 25MG * 50MG * 7~S * lOOMS *

lSOMGU VANGARD LABS/MWM

WESTERN RES LABS WEST-WARD

10HGU*~MGU*50MG~*75MG~* 100MGu 25BGu lOHGt! * 2SMGu * SOMGn

AMPHETAMINE ADIPATEj AMPHETAMINE SULFATE; DEXTROA~IPHETAMINE

ADIPATE; DEXTROAMPHETAMINE SULFATE (PAGE 9)

CAPSULE; ORAL DELCOBESE I P tt¢P. '¢Jtttlj¢fitl

LEMMON

TABLET; ORAL DELCOBESE I P tt¢P. ' ¢Httlj¢#/

LEMMON

I ;i.: ~~M; ;i.: ~~r1¢};C ~~J1M;:': i~M, ',*.' i.: ~M¢.U I ~,:~r1Mi.:~MM i,: ~M¢. 'l':3,:.7~f.¢} :3,:,1~M¢.;1 1:3,:j~t\M:3,:.7~r1¢,' f, '~r1¢.;~M.; ~r1¢.;~r1~/

1.25MG;1.2SMGil.2SMGil.25MG * 2.SHG; 2.5MGi2.5MGi2.5HG * 3.75MGi3.75MGi 3.75MG;3.7SMG * SMGiSMG;5MGiSMG

Ij:~~MG!;i:~~J1G:j:~~MG!j:~~MG'*'~:~lG!/ I l: ~M;j,:~r1Ml: ~~¢. 'l'i:7~r1M~:::1~~l;/ 1~.:.1~tl¢.;~.:.1~J1¢, 'f, '~tlM~~lM ~t\¢.;~J1~/

1.25MG;1.2SMGil.25MG;1.2SMG * 2.5MG; 2.5MG;2.SMG;2.5MG * 3.75MG;3.7SMG; 3.75MG;3.75MG * SMG;SMG;5MG;SMG

AMPICILLIN/AMPICILLIN TRIHYDRATE (PAGE 10)

CAPSULE; ORAL

IP'~)~! ItM ~tV IEQ'zsdMG 'SASE 'f:Eg 'sddHG 'BASE!

POWDER FOR lAS! IP'tl~)W RECONSTITUTION; IMY ~~I O.AL

ASPIRIN; BUTALBITALj CAFFEINE; PHENACETIN (PAGE 11)

CAPSULE; ORAL A.P.C. WI BUTALB%TAL

AS CHELSEA LABORATORIES 200MG;50MG;40~!G;130MG~ BUTAL ct!M~emm

AS CORD LABORATORIES 200MG;SOMG;40NG;130HGtt I"J:n!U::N,~L

AS SANDOl PHARMS/SANDOl 200MG;S0M3;40MG;130HG LAWJ~:INAL

AB LANNETT 200M!HSOH!H40MtH~~

TABLET; ORAL BUTAr..BITAL WI APe

AB LEDERLE LABS/AM CYAN 200MG;50MG;40MG;1!O~G~ LAHO~:r.NAL

.@ LANNETT 20t;II~G; SNlG; 40MG; l!OMG:t PHF.H~~rAL

AB PHOENIX LABORATORIES 200MG;5CHG;40HG;~n

ASPIRIN; CAFFEINE; PHENACETIN; PROPOXYPHENE HYDROCHLORIDE (PAGE 12)

CAPSULE; ORAL DAR VON COMPOUND IUf.: tf.tf.:f I / #!J1¢';'3.2.:~~¢J;l~~r1¢.f:3.2J1~1

ELI LILLY INDSTRS/PR 227MGi32.4MG;162MG;32MG DA~VOH C~M~CU~O-6S

IW 1(,-j.,'ti.f-t'JI /22iMG;:5i:4~l[HUiHM6~t~e! AA ELI LILLY INDSTRS/PR 2271·\l;;52.4MtH162rl1.>;6,,,W3

ASPIRIN; OXYCOIJO:--lE HYDROCHLORIDE; OXYCODONE TEREFHTHALATE (PAGE 12)

TABLET; ORAL cnr.OXY

AA HALSEY D~UG ~25!~~;4.!MG;O.Z8~Gn OXYN'I)C'XE 1\"'0 A~prRXH FUl.!,-ST~F.HGTH

AA ROXANE ,LABORATORIES 3~S~~3;4.5r!G;o.!aMGn OXYC~")nH!!: A!m ~s~:!~m HALF-STRF.HGTH

AA ROXANE LABORATORIES !2!;l'm;2.2!.'HtHO.19NGu OXYC,eMHE W/ ASP!~!H

AA BARR LABORATORIES 325~I!H4.S1·!G;O.38MSU prmct'!JAH

AA ENDO LABS/DUPONT 32SMG;4.SMG;O.!~~G PERC~!)~H-!)E!1::t

AA ENDO LABS/DUPONT 325~IG;2.2SMG;O.19HG

ASPIRIN; PROPOXYPHENE HYDROCHLORIDE (PAGE 12)

CAPSULE; ORAL DAR VON 14/ ASA Itt-t. 'tf.tt;il l~i~tlMp~MI

ELI LILLY I~~STRS/PR 325HG;6SMG

Page 10: APPROVED PRESCRIPTION DRUG PRODUCTS

DRUG PRODUCT LIST / CUMULATIVE SUPPLEMENT NUMBER 12 / AUGUST '81 - AUGUST '82

ATENOLOL (PAGE 12)

TABLET; ORAL TENORMIN

STUART PHARMS/ICI AM 50MG~ * 100MG~

ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE (PAGE 13)

AA

AA AA

1M! AA

SOLUTION; ORAL DIPHENOXYLATE HCL AND ATROPINE SULFATE

ROXANE LABORATORIES 0.025MG/5ML;2.5MG/5ML~

TABLET; ORAL DIPHEHOXYLATE HCL Atm AlltOPIHE SULFATE

WEST-WARD O.02SMG;2.SMG~ DIFHEHOXYLATE HCL WI ATROPINE SULFATE

ICN PHARMACEUTICALS O.02SMG;2.SMG~ PREMO PHARM LABS O.025MG;2.SMG~

1~j.Jl,:t.~:f..fi.r,~)'JrV 16 :6iEli'ltHi :~i'\G! WESTERN RES LABS O.025MG;2.SMGn

AZATADINE MALEATE; PSEUDOEPHEDRINE SULFATE (PAGE 13)

TABLET, CONTROLLED RELEASE; ORAL TRINALIN

SCHERING IMG;120MGn

BACAMPICILLIN HYDROCHLORIDE (PAGE 13)

POWDER FOR RECONSTITUTION; ORAL SPECTROBID

PFIZER LABS/PFIZER 125MG/5MLn

BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE (PAGE 14)

OINTMENT; OPHTHALMIC ZINC BACITRACIN, NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND

HYDROCORTISONE PHARMAFAIR 400 UNITS/GMil7.;EQ 3.5MG BASE/GM;

5,000 UNITS/GM~

BACLOFEN (PAGE 14)

TABLET; ORAL LIORESAL OS

GEIGY/CIBA-GEIGY 20MGn

"-':"

_DlT > .-ill:L>

- DLT >

.'

BECLOMETHASONE DIPROPIONATE (PAGE 14)

AEROSOL; INHALATION/NASAL BECONASE

BN GLAXO 0.042HG/INH~

VAt~CENASE

BN SCHERING O.042MG/INH~

IBENOXAFRdFEH!(PAGE 15)

tffi.~f-tj.i:PRfi.f..1 IP/P6~~~X~, ''II

F~,L. ~,L~~. I ~.O,otl~P, ',*, '~,o,ot\¢pl

BENOXIN.<l.TE HYDROCHLORIDE (PAGE 15)

BETAHETHASONE VALERATE (PAGE 16)

I ##p;3.0(r 'jppf-¢'fi.f-1 IYMj.;3P!4tl

1;3.CHtpf-NM 1,0 ,: f..'~1-1

BROMOCRIPTINE MESYlATE (PAGE 17)

CAPSULE; ORAL PARlODEL

SANDOZ PHARMS/SANDOZ EQ 5MG BASE~

BROHPHENIRAHINE MALEATE (PAGE 17)

ELIXIR; ORA l B~CMPH~rRA~H~ MALEATE

AA PHARHS ASSOC/BEACH 2MG/SMLU

BUPIVACAINE HYDROCHLORIDE (PAGE 18)

INJECTABLE; INJECTION S EHSl'RC,~!HE

AP ASTRA PHARM PRODS O. ZS"/'u If O. Si!n If O. 7S?u

4

Page 11: APPROVED PRESCRIPTION DRUG PRODUCTS

•' ", r ,i

DRUG PRODUCT LIST / CUMULATIVE SUPPLEMENT NUMBER 12 / AUGUST '81 - AUGUST '82 5

BUPRENORPHINE HYDROCHLORIDE (PAGE 18)

INJECTABLE; INJECTION BUPRENEX

NORWICH-EATON/MORTON EQ 0.3MG BASE/MLu

BUTABARBITAL SODIUM (PAGE 18)

ELIXIR; ORAL SARISOL

AA HALSEY DRUG 30MG/SMLU

1M! AA

lID 1M!

AA

TABLET; ORAL sonIUM BUTABARBITAL !¢iliiil.'(l¢ilFlAfil#OiiiV 1:l6:ZMG ';':3Z:4MG!

BUTABA!"!BITAL SODIUM CORD LABORATORIES lSMG * 3CMG

Itltl:tlfi$:tl r!'d~\d! -BunSOL SODIUM 7il¢iid('tfi.J3ijRfijPPjt$llgB~';':3dMG';':iddHG!

I. I WALLACE LABS/C-W ISMG * 30MG * lOOMG

50MG

CAFFEINE; ERGOTAMINE TARTRATE (PAGE 19)

TABLET; ORAL ICAFFE:tNi!t 'AHO 'E~GdTAM:tHE 'TkRTRIdE!

ERCATAB

CALCIFEDIOL (PAGE 19)

CAPSULE; ORAL

IP1~~?;~~~~,~tA 'PPs:tttl J.d,:1-'!>, '!.)~tl, 'f., ',d,:,!>, 'Y~IV

CALCITRIOL (PAGE 20)

CAPSULE; ORAL ROCALTROL

HOFFMANN-LA ROCHE 0.25 UGM * 0.5 UGM

CALCIUM CHLORIDE; DEXTROSE; GLUTATHIONE DISULFIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BTCARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE (PAGE 20)

SOLUTION; IRRIGATION BSS PLUS

ALCON LABORATORIES 0.lS4MG/ML;0.92MG/ML;0.184MG/ML; 0.2MG/ML;0.38MG/ML;2.1MG/ML; 7.14MG/ML;0.42MG/MLU

/;tNH¢:t#tt.f, 'jN.Jt¢fjPNI

I j~~~~B~J: :~~~~~~§~~~i~7j1g:~J~~~j~~~{J;~~~~'1~~~{; I I jMtp$p.L. '~', 'ptX:tpp,st,' /~~?~~~M~~Ji~:~~~~~~~~~~lp1-tl~),t,d.dtl.LI

I fi~f!p:t:t, '.Lfi~ppfifppjt$1 ~i~J~~~l~:~~£:~~:~i~~~i~~M:~~~1-tl¢),tP.dtl.LI

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE (PAGE 20)

INJECTABLE; INJECTION DIALYTE WI DEXTROSE 1.S/o IN PLASTIC CONTAINER

AM MCGAW/AM HOSP 29MG/IOOHL;1.SGM/IOOML;lSMG/IOOML; 610MG/IOOML;560MG/IOOMLU

DIALYTE WI DEXTROSE 4.25/0 IN PLASTIC CONTAINER AM MCGAW/AM HOSP 29MG/IOOML;4.25GM/IOOMLi15MG/IOOML;

610MG/IOOML;560MG/IOOMLU

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUH CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE (PAGE 20)

>~> AT >....8J2!L> AT

>2Q!L> AT >2Q!L> AT

>2Q!L> AT >....8J2!L> AT

>~>

> ADD > AT >~> AT >....8J2!L> >~> AT >~> AT >~>

>2Q!L> AT > ADD > AT

SOLUTION; INTRAPERITO~EAL Dn,HEAL ~D-2 WI DEXTI<OSE 1.5? :T.H PLAsnc C'HTAT.HF-R

TRAVENOL LABS 25. iMG/ICOMLa.SG!YIOC~11.~ S. Og~:G/IOC~IL ;s!?w?n.a::l~~!..;44~NG/I00HLu

DIAHEAL ~O-2 WI DEXT~OS!! 2.S?' IN PLASTIC C~HTA!HER TRAVENOL LABS 2S.7M9/HlC!!L;Z.5SM/1ClJllL;

S. OmlG/IMNI.; S:!r.Nt::/I00'lL ;4~FMG/IOOHLlS D!ANE,AL F'D-2 WI DEXTROSE 4.257. Iii PI.A!1T!C C~HTAItI: .. ~

TRAVENOL LABS 25.'HG/IOQML;4.25r;~llonML; 5. 08~'!8/1MM!.; 53'3~!SIlOmlL;44mjG/lOOMl.U

INPERSOL WI DEXTROSE 1.S/o IN PLASTIC CONTAINER ABSOTT LABORATORIES 2S.7HG/IOOML;1.5GH/IOCML;

IS. 2HG/IOOHL ;56 7HG/IOO~tL; 392HG/I00HLU INPERSOL W/ DEXTROSE 2.S1. IN PLASTIC CONTAINER

ABBon LABORATORIES 25. 7HG/IOOHL;2.5GH/IOO~!L; 15.2MG/IOOML;567MG/IOOHL;392MG/IOOHLU

INPERSOL WI DEXTROSE 4.251. IN PLASTIC CONTAINER ABBOTT LABORATORIES 2S.7HG/IOOML;4.25GH/IOOML;

lS.2MG/lOOML;S67MG/160ML;392MG/lOOMLU D!PERSOI.-lM WI !)EXTPOSr. 1.S7. II{ PLASTIC C!',{TA!l{~

ABBon LABORATORIES 2$. 'Mt'/lnoMLa.m:~l.ylOf)HL; 5. OP~lG/IN1ML; 5:!iS1':G/l OO~L; 448HG/IOOtllu

!HI'ERSOl-LM WI DF.XTrOSE 2.57. :rtf I'LASTIC C~~iTAlm:R ABson LABORATORIES 25. 'MG/lOO~ILa • .sr;H.Il,OVHl;

S. OBMS/lanHL ;5:!8m~/J,O!.'f'll ;448HG/IOOHLU IHPERS~L-LM WI CEXTROSE 4.257. IN PLASTIC ce~TAIHER

ABson LABORATORIES 25. 7tlG/IOOHLFl>. 2!;GHn.CotIL; 5. (!SNG/loaML;5=EHG/lorM!..;4l;B~IG/1OOML~

.~,.~ .;':",\'C'

Page 12: APPROVED PRESCRIPTION DRUG PRODUCTS

'::;:;.'" DRUG PRODUCT LIST / CUMULATIVE SUPPLEMENT NUMBER 12 / AUGUST '81 - AUGUST '82

CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE (PAGE 21)

INJECTABLE; INJECTION DEXTROSE ~/. ZH LACTATED RZHGE~'S ZH PLASTIC COHTArNER

AP CUTTER LABORATORIES 20MG/100ML;SGM/10~~L;30MG/100ML; AP 600HG/100ML;310MG/100HL~

CALCIUM CHLORIDE; MAGNESIUM CHLORIDE, HEXAHYDRATE; POTASSIUM CHLORIDE; SODIUM CHLORIDE (PAGE 21)

SOLUTION; PERFUSION, CARDIAC ABBOTT'S CARDIOPLEGIC IN PLASTIC CONTAINER

ABBOTT LABORATORIES 17.6MG/I00ML;325.3MG/I00ML; 119.3MG/I00MLi643MG/I00ML~

CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE (PAGE 21)

AT

CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE (PAGE 21)

SOLUTION; IRRIGATION LACTATED RINGER'S IN PLASTIC CONTAINER

TRAVENOL LABS 20MG/I00ML;30HG/I00MLi600MG/IOOMLi 310MG/I00ML~

CALCIUM GLUCEPTATE (PAGE 21)

INJECTABLE; INJECTION CALCZUM BLUCEPTATE

>~> Af ABBOTT LABORATORIES EQ 90MB CALCDUM/5ML >~> AP INTL MEDICATION SYS EQ 90MG CALCZUM/5~lL~

CAPREOMYCIN SULFATE (PAGE 22)

INJECTABLE; INJECTION CAPASTAT SULFATE / tf.:J.: j.j.j..f.:j / / t~' f.MJi: f!,fi,U)Y f-fi,U

ELI LILLY EQ IGM BASE/VIAL

CARBAMAZEPINE (PAGE 22)

TABLET, CHEWABLE; ORAL TEGRETOL

GEIGY/CIBA-GEIGY 100MG~ •;' " c ~..p

>.JL!:L> >.JL!:L> >.JL!:L>

CARBINOXAMINE MALEATE (PAGE 22)

/ t7~zi~~;~'ifi.L/ / tiS:Ntf-t.. 'p]-t,t\.RIV /,tlJi),SMU

CARISOPRODOL (PAGE 23)

TABLET; ORAL CAR!SCF~O!)OL

AA DAt~8URY PHARMACAL ~50H3!!

/"l!d / p]-t;"ptlfip;YNt:j..;"i3~/ /3SoiH! AA CHELSEA LABORATORIES 3S0!'lG

CEFADROXIL (PAGE 23)

TABLET; ORAL DlIm:CEF I thiN ')P]-tN~PtVi3 . .:tl/ jj.r),tV

AS MEAD JOHNSON/B-M E9 16M BASE ULTRACEF

AS BRISTOL LABS/B-M EQ 16M BASEl:I

/C~PH~AO:t~iE(( PAGE 24) CEPHRADINE/CEPHRADINE DIHYDRATE (PAGE 24)

CAPSULE; ORAL /V'fi.lOSF..F!

/ill /tR#~fi)p.R)tR:~~f-i3M /2sdHG 'f..''sdor-ltV VEL05EF '2:50'

AS ERSANA/PR/ER SQUIBB 25CMG * E9 250MB fASEn VELOSEF 'seo'

AS ERSANA/PR/ER SQUIBB 500MG * E9 500M6 BASE~

POWDER FOR RECONSTITUTION; ORAL /Vtr:.OSEFI

/ AM h#$}.Nfi)PB)tB. '~.Q.Uf-;3f!,/ /ii.IjMG)SHl '.*.' 25d~I(VS~IU VELCSEF '12's'

AS ERSANA/PR/ER SQUIBB 125MG/SML VELOSEF '250'

AS ERSANA/PR/ER SQUIBB 2S0HG/SML

CERULETIDE DIETHYLAMINE (PAGE 25)

INJECTABLE; INJECTION TYMTRAN

ADRIA LABORATORIES 0.02MG/ML~

6

Page 13: APPROVED PRESCRIPTION DRUG PRODUCTS

. . • ' • • DRUG PRODUCT LIST / CUMULATIVE SUPPLEMENT NUMBER 12 / AUGUST '81 - AUGUST '82 7

CHLORAMPHENICOL (PAGE 25)

SOLUTION/DROPS; OPHTHALMIC AHTIBIOI'TO

AT PRO PHARM/STERI-MED O.~/.~

CHLORAMPHENICOL AT MAURRY BIOLOGICAL O.57.~

CHLORAMPHENICOL PALMITATE (PAGE 26)

SUSPENSION; ORAL ICtiLdRAMHEHicdL • PALMItATE!

I~ /PAPRt;PAyj$)W;t/ /eg'isoMG'sAsE)sMll

CHLORAMPHENICOL SODIUM SUCCINATE (PAGE 26)

AI' 1m

AI' >....8!llL> AI'

IW AI'

IW AI'

INJECTABLE; INJECTION CHLORAMI'HEH!COL SOnIUM SUCCINATE

BOEHRINGER MANNHEIM Ed l~H BASE/V!AL~ Ipp»l. '¢tltr1.t¢fi.(1 IE 'iocHa '~l5VHL!

DOW CHEMICAL E9 1GM BASE/VIAL L YPHO-MED E9 1~t1 BASE/v:rAL~

CHLO~OMYCET:m

/PApRt;pJyj$!~~tl PARKE-DAVIS/W-L

MYCHEL-S IP#HUU. 't#~1

RACHELLE LABS

IEQ'idOMG'BASE)MLI Eg IBM BASE/VIAL

IEQ 'idd~iG 'BAStJMU EQ 1GM BASE/VIAL

CHLORDIAZEPOXIDE HYDROCHLORIDE (PAGE 26)

CAPSULE; ORAL CHLC~DIAZEI'OXIDE HOL

AB ASCOT HOSP PHARMS 5MG~ * 10MG~ * 25HG~

CHLOROPROCAINE HYDROCHLORIDE (PAGE 27)

INJECTABLE; INJECTION CHLOROPROCAINE HeL

AP ABBOTT LABORATORIES 2~ * 37.~

HESACAIHE-CE AI' PENNWALT PHARM 27. * 37.

CHLOROQUINE PHOSPHATE (PAGE 27)

AA 1m

AA

TABLET; ORAL CHL~RO~UIHE PHOSPHATE

BICCRAFT LABS I ~t fiN.Lfi#!M.MpAKI

PUREPAC/KALIPHARM

E~ 150M!; BASElS iE ':£SotH 'BAstl

Eg 150~lG BASE

CHLOROTHIAZIDE (PAGE 27)

TABLET; ORAL CHLO~l:lTHIAZIDE

AB WEST-WARD 250MGlS * 500!,,:G~

CHLOROTHIAZIDE; RESERPINE (PAGE 27)

TABLET; ORAL CHLOROTHIAZIDE-RESERPINE

BP MYL.~N PHARMS 250MG;O.125MGU * 500MG;O.125MG~ DIUPRES-500

BP MS&DIMERCK 500MG;O.125HG

CHLORPHENIRAHINE MALEATE (PAGE 28)

AA

IW AA

AA

SYRUP; ORAL CHLORPHEHn'AH!HE MAI.EATE

PHARMS ASSOC/BEACH 2MG/5MlU

TABLET; ORAL CHLORFHEHZRAMIHE MALEATE /HAt#J.'PR0¢/ /4I-lM

SUPERPHARM 4~lG~

KLtlI10M:!H HALSEY DRUG 4HG

CHLORPROMAZINE HYDROCHLORIDE (PAGE 29)

CONCENTRATE; ORAL CHLC~p~e!lAz:rNF. HCL

AA BAY LABORATORIES

INJECTABLE; INJECTION CHLORPR()M.~Z:rHE HCL

30HB/ML~ * 10CMG/ML

I W , 7Mt~HA/1.' t#$)#l¢tlfitV 2$1G)I~(f TABLET; ORAL

CHLORPROMAZINE HCL >....8!llL> BP VANGARD LABS/MWH lOMG~ * 25HG~ * 50MG~

CHLORTHALIDONE (PAGE 30)

TABLET; ORAL CHLORTHAL!:l)C~E

AS CHELSEA LABORATORIES 25MG~ * 50MGu AB DANBURY PHARMACAL 25~IGU * 5CtlGn AB VANGARD LABS/MWH 25MG~

Page 14: APPROVED PRESCRIPTION DRUG PRODUCTS

DRUG PRODUCT LIST / CUMULATIVE SUPPLEMENT ~VMBER 12 / AUGUST '81 - AUGUST '82 8

CHLORZOXAZONE (PAGE 30)

TABLET; ORAL CHlClRZOXAZOHE

> ADD > AA CHELSEA LABORATORIES ~U AA DANBURY PHARMACAL 250MGU

PAIMFLEX AA MCNEIL LABORATORIES ~

CISPLATIN (PAGE 31)

INJECTABLE; INJECTION PLATINOL

BRISTOL LABS/B-M lOMG/VIAL * SOMG/vIAL

CITRIC ACIDi MAGNESIUM OXIDEi SODIUM CARBONATE (PAGE 31)

SOLUTION; IRRIGATION IRRIGATING SOLUTION G IN PLASTIC CONTAINER

TRAVENOL LABS 3.24GM/IOOML;380MG/IOOML;430MG/IOOMLU

CLOMIPHENE CITRATE (PAGE 31)

TABLET; ORAL CLOMID

BP MERRELL-NATL/R-MERRL SOMG CLOMIPHENE CITRATE

BP PLANTEXlIKAPHARM SOMGu

CLOXA~ILLIN SODIUM (PAGE 32)

/ ~%r;f~~~· :~~~~~p~;fYrV /~1P¢~~f j. '~fi¢'~/ / t..rt 'ji~J1¢. '¢'fi~t.l>J1f./

POWDER FOR RECONSTITUTION; ORAL CLOXAC%LL%H 50D%UM

AB BIOCRAFT LABS EQ 125MG BASE/SML TEGOPEH

AB BRISTOL LABS/B-M Eg 125MG BASE/5ML

COPPER (PAGE 33)

INTRAUTERINE DEVICE; INTRAUTERINE /¢pppt.~'ll

/PPPyj:;(f;fPN.'¢PYN¢;ft/ /j#J1f,/

CROMOLYN SODIUM (PAGE 34)

SOLUTION; INHALATION INTAL

FISONS lOMGIMLU

CROTAMITON (PAGE 34)

AT

AT

LOTION; TOPICAL CROTAN

OWEN LABS/DERM PRODS 107.U EU~AX

WESTWOOD PHARMS 107.

CYCLOPHOSPHAMIDE (PAGE 36)

INJECTABLE; INJECTION CYTOXAH

AP MEAD JOHNSON/B-M 100MG/V%Al * 200flG/'f!Al * 50CM5/V:IAl HEO!;A~

AP ADRIA LABORATORIES 100M~/V:r.Alu * 20C~,,:VVIAL!I: * AP 500MG/V:rAlu

CYPROHEPTADINE HYDROCHLORIDE (PAGE 36)

AA >~>/W >....8QlL> AA

TABLET; ORAL CY~~OHF.~TAOIHE Hel

DANBURY PHARMACAL / PR.EriP.' ptlfiRri.' f./ .. rfo$/

LEMMON

4MGlS /'lMGd/

c;'MGn

DESIPRAMINE HYDROCHLORIDE (PAGE 38)

TABLET; ORAL NORPRAMIN

MERRELL-NATL/R-MERRL lOMG~ * 2SMG * SONG * 7SMG * lOOHG * ISOtlG

/oEsI'lMRiffS!H/(PAGE 38) DESHOPRESSIN ACETATE (PAGE 38)

SOLUTION; NASAL DDAVP / f .ER.R;t~¢. 'ptlfi.RriM

ARMOUR PHARM

DESOXIMETASONE (PAGE 38)

GEL; TOPICAL TOPICORT

HOECHST-ROUSSEL

/ P,:j.rif,)J1f.1 O.IMG/ML

O.OSr.U

Page 15: APPROVED PRESCRIPTION DRUG PRODUCTS

• i. DRUG PRODUCT LIST / CUMULATIVE SUPPLE.MENT NUMBER 12 / AUGUST • 81 - AUGUST • 82 9

DEXAMETHASONE (PAGE 38)

TABLET; ORAL DEXAMETHASONE

>.Jll:L> /r,P! >.Jll:L> /~P! >...!lliL.> BP >...!lliL.> BP

/ ptltf-tp,/>. 'R.d#Nt. 'f-Ar,,/>I /.d,: .2~J1~. 'tf. ',d ,: ~J1,G: tf. '.0 ,: .7~J1,G, 'tf. 'J:.: ~M. 'fl /fitl~1

ROXANE LABORATORIES 0 . 25~IG * O.5MG * O. 75MG * 1. 5MG * 2MGn: 4MG

BP UPSHER-SMITH LABS o . 75HGn: * 1. 5MGn:

DEXAMETHASONE ACETATE (PAGE 39)

INJECTABLE; INJECTION DEXAMETHASONE ACETATE

BP CARTER-GLOGAU LABS EQ 8MG BASE/ML EQ 16MG BASEIMLn:

DEXAMETHASONE SODIUM PHOSPHATE (PAGE 39)

INJECTABLE; INJECTION DEXAHF.THASOHE SOn!UM PHOS~HATE

/ ill IME¢MA,'tA~~)UiCtifiNtg 'c;orla 'PHOSPHATE/r-IU AI' CARTER-GLOGAU LABS E~ 4HG Il'N05FHATE/Hl. IE

AP Eq 10M3 PHOS~HATE/MLn: IE

!f E9 Z4M3 PHOSPHATE/~!L AP NATCON CHEMICAL Eq 4N3 Il'HOStlHATE/MLll

HEXADROL PHOSPHATE AP ORGANON/AKZONA EQ 4MG PHOSPHATE.lML IE

AP Eq 10113 PHOSPHATE/HL

DEXCHLORPHENIRAMINE MALEATE (PAGE 40)

SYRUP; ORAL POLARAMINE

SCHERING

DEXTROSE (PAGE 41)

INJECTABLE; INJECTION

2MG/5MLn:

DEXTROSE Z07- IN PLASTJ:C COHTAJ:NER AP ABBOTT LABORATORIES 20GH/IOOHLn: ~ TRAVENOL LABS 203M/l00ML

DEXTROSE 407- IN PLASTJ:C CONTAINER AP ABBOTT LABORATORIES 4CGM/100MLn: AI' TRAVENOL LABS 40GM/100HL

DEXTROSF. 50% IN PLASTJ:C COHTAJ:HER AP ABBOTT LABORATORIES 50GH/100MLll AP TRAVENOL LABS SOGM.llOOML

DEXTROSE 607- :tN PLASTIC CONTAJ:H~R AI' AM MCGAW/AM HOSP 60GM/l0011l AI' TRAVENOL LABS 60G~1/100MLn:

DEXTROSE 707- IN PLASTIC caHTAIN~R AP ABBOTT LABORATORIES 70GM/100HLn: AP TRAVENOL LABS 70SH/100ML=

DEXTROSE; DOPAMINE HYDROCHLORIDE (PAGE 41)

INJECTABLE; INJECTION DOPAMINE HCL IN DEXTROSE 5%

ABBOTT LABORATORIES 5GM/100ML;80HG/100HLn: * 5GH/IOOML;160HG/IOOML~

DEXTROSE; LIDOCAINE HYDROCHLORIDE (PAGE 41)

AI'

INJECTABLE; INJECTION Ll:DOC,UHE KCL 0.47. AHD

TRAVENOL LABS LIDOCAINE HCL 0.8% AND

TRAVENOL LABS

DEXT~OSE ~/. IN PLASTT-C CONTA~N~ 5GM/IOCHL;400MG/IOOHLn: DEXTROSE 5% IN PLASTIC CONTAINER 5GM/100ML;800MG/100MLn:

DEXTROSE; POTASSIu~ CHLORIDE; SODIUM CHLORIDE - IN PLASTIC (PAGE 43)

INJECTABLE; INJECTION DEXTROSE 5%, SO!ll:UM CHI.CmrO EO. Z% AND FOTASSJ:tJM CHLORl"D E

0.075% AI' AM MCGAW/AM HOSP 5GM/IOOHI.;14.S~~/lCC~11_;20')t:'3/1I)OM'JI

lID IfRAytNPf-:f-fir,'/>! I~GrViodf\L;j!Sr~~;iiB~lVJ3~~Ii!hM4Ll OF.Xi1<CSE 57-, S~D:tUM CHlO~InE 0.2? A~m PO·T~,SS'j,ml C;"Ln~:tI)E

0.15% ! fJj nmtNPf-:f-l~,/>! Is1M):(rlO·.jU:i.50M~li6~M(;,2(\O~1h:rldMLI

DEXTROSE 5%, S01):tl'M CHLORIDE 0.2% AND I'OTA:;S:;;UM C:iLc!~![l£

5MEg (K) AI' TRAVENOL LABS 5ml/lOO~IL;7:!"M!.Y10CML;200~G/l!lt)ML IE

AI' :smV10nHL;!SOHrVlcr,Hf.;?rHlMS/lOrlHI. - DEXTROSE 57-, SllnIUM CI!LOnDE 0.2% Mm I'l)TAESn!~ Ctil.C~ID=

lO!1!!q (K) AP TRAVENOL LABS SGM/IOOML;1!;l'IGI:!.OOMl.;Z!)OmVIMML IE

AI' SGlVION1L; l.5C~!r,/lOcn'L; ?,O()~m/l!)o!'IL DEXT~ClSE 5%, SeD:tUM CHLO~XDE 0.2? A!-m POTA~SJ.l!M CHLC~!n=

0.224? I fJj ~NPf-:,Lfirf,,/>/ !s~Mii!lClll;'2i4f.~Jicd~ll;'20;\~~3):(tlOHt/

DF.XT~OSE 5%, SODIUM CHLO~IDE 0.27- AHlJ j::OTA~S!tJli CHLO~IDE

15M;;q (K) AP TRAVENOL LABS 5!3M/1OO!'IL ;Z?4MG/10CtlL; 201"1~G/I00!1L

D EXTRCSE 5% t SO!)IUH CtlLo~In EO. 2% AMD POTASSIUM CHlCnn E 0.3%

I fJj mAyt~Pf-:t.A~'f>I !SGM)idCHl;'5t1t1~\r-\)H6HL ;2t1cl~lGh'd6~LI DEXTROSE 5%, SeDIUM CHLeR!!)!;: O. Z% Atm PCTASS:tl'H CHLO~InE 20HE~ (K)

AP TRAVENOL LABS !mM/lOOMLa50~IG/lOOML;znOM~/IOOML * AP SGM/IOO~lL; :,IOOMS/lOO:",l; 2(),n:G/IOOML - DEXTROSE 5%, SODIUM C:iLO~I[lE O. 2% A~m POTA!;S!l!H C~lLC~IDE

30M!;'Q (K) AP TRAVENOL LABS 5GM/IO(\ML;224MG/leO~L;20~MG/100ML - DEXTROSE 57-, SODIUM CHLORI!)E 0.2% t\H!) rOTAS!'J:UH CHLo~::mE

4fJMEq (K) AP TRAVENOL LABS 5GM/lOOML;300HG.ll,OCMl..;Zoc:-m/10ClMI.

Page 16: APPROVED PRESCRIPTION DRUG PRODUCTS

DRUG PRODUCT LIST I CUMULATIVE SUPPLEMENT NUMBER 12 I AUGUST '81 - AUGUST '82 10

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE - IN PLASTIC (PAGE 43)

DEXTROSE ~/.t SODZUM CHL~RIDE G.!!? AHD POTASSIUM CHLORZDE SMEQ (K)

AP TRAVENOL LABS SGM/IOOML;75MG/IOOML;!30MG/IOOMLn DEXTROSE S?'t SODZUM CHL~RiDE O.!!? AND POTASSZUM CHLORIDE lO~lEg (K)

AP TRAVENOL LABS SGM/IOOML;75MG/IOOML;!30MG/IOOMLn * AP SGM/lCO~lL; lSOMG/IOOML; 3:1Otnm/lOOMLn

DEXTROSE ~/.t SODZUM CHLORIDE O.!!? AHD POTASSIUM CHLOR!DE lSHEg (K)

AP TRAVENOL LABS S[>M/IOOML;224HG/IOOML;!3C1'":GIlOO~lLn

DEXTROSE ~/.t SODZUM CHU!R!OE O. !3? AWl POTASSIUM CHLClRZDE 20MEg (K)

AP TRAVENOL LABS SGM/IOOML;lSOMG/IOOML;330MG/IOOMln * AP SGM/IOOML;300MG/IOOML;330M5/100MLn

DEXTROSE ~/., SOD:nJM CHLCRZDE O.!!? AND POTASSruM CHLORIDE !OHEg (K)

AP TRAVENOL LABS SGM/IOOML;224MG/IOOML;!30MG/IOOMl~

DEXTROSE S?'t SODIUM CHLORIDE O.!!? AND FOTASS~UM CHLORIDE 40MEg (K)

AP TRAVENOL LABS SGM/IOOML;!OOMG/IOOML;!!OMG/IOCMLn DEXTROSE S?, SOD ruM CHLORIDE G.4S?' AMD POTASSIUM CHLORIDE

O.07S? AP AM MCGAW/AM HOSP SGM/IOOMl;74.5SMG/IOOML;4S0MS/IOOMLn

/ill lf~fi':Jtr.p( 'f-firp~1 lilGiVi6t\~I( ;7il~iOid6i'll ;~50~HhoaHl/

1M! AP

/ill

AP AP

AP AP

1M!

AP

1M! AP

/ill

AP AP

AP

DEXTROSE S?'t SOD:nJM CHLa~IDE O.4S? A~m POTAS!;:!!!!'! CHLCR!!lE O.15X 7lUP'f'f.'f-I..rppF.fi'fp~f.tM ISGMJioOML;isd[1GJiodH(;4SrlHGJt6~~U

ABBOTT LABORATORIES SGM/IOOMLa49~lG/IOCML;4SCHG/IOOML

1f~fi':JtMf-.' f-fi.rp~1 lilGiViilo,,!( ;isdt!ah06tl( i4sYiiOi d O!,jL/ DEXTROSE S?. SODIUM CHLORIDE O.4S? ANn POTASSIUM CHLOR!DE ~lEg (K)

TRAVENOL LABS SGM/IOOML; 75MG/IOOML;4SC~!G/!OC'iL * SGH/IOOtil; lSO~~G/ICOI1L;4S(!r-:G/l om1L

DEXTROSE ~/., SODruM CHLORIDE O.4S? AND I=OTASS!:UM CHLOR"I'ne lOHEg (K)

TRAVENOL LABS SGM/IOOML;75MG/IOOML;45CMG/1CGML * SGM/10CML;lSUMG/IODML;450MG/IODHL

DEXTROSE S?, SOD:nJM CHLORIDE O.4S? AH!) POTASS!:UM CHLORIDE O.224? mmNP('f-#~1 ISGrViodML;224tIGJi6d~\L;C;56~jGh:d6~jLI

DEXTROSE S?, SODIUM CHLORIDE O.4S? AND r.OTASSIUM CHLO~IDE lSMEg (K)

TRAVENOL LABS SGM/IOOML; 224MG/IOOHL;4S0!'!:;!1(!m~l_ DEXTROSE S?'t SODIUM CHLORIDE O.4S? AHD FOTASS!:UM eW_tRIDE

O.3? ' !mpf'f. 'f-#p~fi'fp~f.t~. '/ssrVidoML ;30dHGJidoML i 4S0MGJiocHU

ABBOTT LABORATORIES SGM/100ML;298MG/1COHL;4S0MG/10I)~~L lf~fi':JtNPf-.' f-firpN IsihVid61( iidrlr,\tViCdi'l( ;~5d~\GJi;Bi'lL!

DEXTROSE S?, SODIUM CHLCRJ:DE O.4S"/' AI-;o POTA.SS:tl!M CHLOR!DE 20MEg (K)

TRAVENOL LABS SGM/100ML;15CMG/IOQML;450MG/IDOML * SGMI'lOOMl;30NIG/IOOMl;4S0"!~/100ML

DEXTROSE S?'t SODIUM CHLORIDE O.4S? A~D FOTASSIUM CHlO~!nE 30MEg (K)

TRAVENOL LABS 5GM/10llML;22411~n.nCML;450·1~/100M'_

> -.ill,L> > -.ill,L> > -.ill,L>

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE - IN PLASTIC (PAGE 43)

D F.:XTROSE 5%. SnD!UM mltOR:!!)" 0.45% AND POU,!'!;::r.VM CHLC!:?Zi) E 40~~EGl (K)

AP TRAVENOL LABS SGH/IO(ll<R;<.!OC~;Gn0Q1,jl;l;,<;~MG/IO~'1L

DEXTROSE; THEOPHYLLINE (PAGE 44)

INJECTABLE; INJECTION THEOPHYLLINE AND DEXTROSE S% IN PLASTIC CONTAINER

TRAVENOL LABS SGM/IOOML;40~!G/lOOMLlt * SGM/IOOML;80MG/,lOOML~ * SGM/IOOML;160MG/I00ML~ * SGf1/100ML;200MG/lOOHLH * SGM/IOOMLi400MG/IOOMLn

DIATRIZOATE MEGLUMINE; DIATRTZOATE SODIUM (PAGE 44)

SOLUTION; ORAL, RECTAL Gt1SiRnG~AF!H

AA ER SQUIBB AND SONS 66?;lO? !1D-t::ASTl<:OVIF.W

AA MAlLINCKRODT 66%;lo?n

DICLOXACILLIN SODIUM (PAGE 4S)

CAPSULE; ORAL D!ClOXAC:r.LL!H sonIUM

AB BIOCRAFT LABS Eft 2:5't"1"G BA,!;'Zt! * En 5NWG B,~SEl!

DIFLUNISAL (PAGE 47)

TABLET; ORAL DOlOBIO

MS&D/MERCK

DIGOXIN (PAGE 47)

CAPSULE; ORAL LANOXICAPS

2S0MG~ * 5001'iGn

BURROUGHS WElLCO~E O.05MGn * O.lHG~ * O.2HG~

DIMENHYDRINATE (PAGE 47)

J ~0pp.o~f.:f.o#.y.r 'f!.H;jfi{..J IPRfil1At1f.N( 'I

J ~tARf-t.' .PHAR;1~J Jf.,o.Otlf,f

Page 17: APPROVED PRESCRIPTION DRUG PRODUCTS

·' • DRUG PRODUCT LIST I CUMULATIVE SUPPLEMENT NUMBER 12 I AUGUST '81 - AUGUST '82 11

DIPHENHYDRAMINE HYDROCHLORIDE (PAGE 47)

CAPSULE; ORAL lMU

1M! Itl/<. 'tp.r,pp,fi.jpp,j.t~1 12SMG'~:SOMG/ DIPHE~!HYD~I\M!H!: MOL

AA HK LABORATORIES 25MG M ~ 50MGU AA VANGARD LABS/HWH

ElIXIR; ORAL I~

1M! Itl/<:Ur,pp,p.fpp,j.t~1 1i2:SMG)SML'1 DIPHENHYDRAMINE HOl

AA HK LABORATORIES 12.SMG/SMl AA PHARMS ASSOC/BEACH 12.5~!G/5MLU

AA PUREPAC/KALIPHARH 12. 5~lG/5~ILJl

DIPHENYLPYRALINE HYDROCHLORIDE (PAGE 48)

CAPSULE, CONTROLLED RELEASE; ORAL HISPRIL

SK&F LABORATORIES 5MG

DISOPYRAMIDE PHOSPHATE (PAGE 49)

CAPSULE, CONTROLLED RELEASE; ORAL NOR PACE CR

SEARLE/SEARLE PHARHS EQ 100MG BASEJl * EQ 150HG BASEu

DOPAMINE HYDROCHLORIDE (PAGE 49)

AP

>~> AP

1M! AP

INJECTABLE; INJECTION DOI'AMTtlE

ELKINS-SINN/AHROBINS 40MG/Ml * 80MG/MLJl DOPAMINE Hel

ABBOTT LABORATORIES 40MG/Ml * 80MG/MLu INTROPIH nil. '¢#j;tj.¢p.(' ¢p.P,t; fi-tiM 40HS)ML

IMtg)ilt. '~.' .i~.dJ1~;tltPi AM CRITICAL CARE/AHS 4(mG/~!L M 80MG/Ml

160MG/MLU

DOXYCYCLINE HYCLATE (PAGE 50)

CAPSULE; ORAL DOXYCYCLINE HYClATE

AB CHELSEA LABORATORIES AB DANBURY PHARMACAL AB MYLAN PHARMS

EQ 50MS BASEU * E9 lOOMS BA~EU E9 lOOMS MSE E9 50MG BASEU M E9 lOOMS BASEU

EDETATE CALCIUM DISODIUM (PAGE 51)

INJECTABLE; INJECTION IYtR~tNf.:jtl

CALCIUM DISODIUM VERSENATE

TABLET; ORAL lytp-$ttlAftl

CALCIUM DISODIUM VERSENATE

EPINEPHRINE; ETTDOCAINE HYDROCHLORIDE (PAGE 51)

INJECTABLE; INJECTION > DLT > Ip0RANtM.·H;.·tpj.N;EP~P,j.f'ltl > ADD > DURANEST

>~>

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE (PAGE 51)

INJECTABLE; INJECTION XYLeM!"'l!: WI !!PZr-;"PHR:tME

ASTRA PHARM PRODS O.005MG/ML;O.5/.~ * O.005MG/ML;1% * O.OOSMG/tlLa.5/. * O.005HG/ML;2/.

ERGOLOID MESYLATES (PAGE 52)

TABLET; ORAL ~r.:;O!..C:!1) ~IESYl,~TES

AB >~> AB

BOLAR PHARtlACEUTICAL lMGll DANBURY PHARMACAL l~Gn

HY!)'-'~G:!NE

AB

AA

At. AA

!#NMi. ' FHJRtit8JNPP,iI.d.: tM.'!.· .iMI SANDOZ PHAR~lS/SANDOZ IM13

O.5~lG

TABLET; SUBLINGUAL D:!HYDI<N,!<5':m'X!'N'E METHAN"5U'_!=tn~TF.

KV FHAR~lACEUTICAL ! is: sila '.*!ltlG E~GOI.O:!D HlES'fLATES

BARR LABORATORIES KV PHARMACEUTICAL

O.5MGlf * lMGJl .Q.8!:ill

ERGOTAMINE TARTRATE (PAGE 52)

TABLET; SUBLINGUAL WIGRETTES

ORGANON/AKZONA 2MGll

Page 18: APPROVED PRESCRIPTION DRUG PRODUCTS

DRUG PRODUCT LIST / CUMULATIVE SUPPLEMENT NUMBER 12 / AUGUST '81 - AUGUST '82 12

ERYTHROMYCIN (PAGE 52)

SOLUTION; TOPICAL ERYDE~M

AT ABBOTT LABORATORIES 20MGIML ERYTHROMYCiH

AT ELI LILLY 20MG/ML AT NATL PHARM MFG/BARRE ~u * 2Zu

STATl:CiH AT WESTWOOD PHARMS ~

AB

TABLET, ENTERIC COATED; ORAL E-MYCiH

UPJOHN 250MG * 333MG ~'f./ /~/ -

ERY-TAB AB ABBOTT LABORATORIES 250MG * 33!MGU ~'f./ /~p.I-

500MGU

ERYTHROMYCIN ESTOLATE (PAGE 53)

AB

IMY AB

CAPSULE; ORAL ERYTHROMYCiH ESTOLATE IN-F#., 't~fi.ffiiUiW 1f.;'<;MrJ,:f:;'<;,dMrJ,1

BARR LABORATORIES EQ 125MG BASE * EQ 250MG BASE nOSONE /ilJ.i,'JA' PRPpf,lf:J.f-{.:J I

DISTA PRODS/LILLY

IEf2SdMG 'BASE! Ii.. 'Oii?!4¢, '¢}.#.I

EQ 125MG BASE * Eg 250MG BASE

ERYTHROMYCIN ETHYLSUCCINATE (PAGE 53)

GRANULE; ORAL PEDiAMYCZH

AB ROSS LABS/ABBOTT Eg 200MG BASE/5ML

It;t~tl;lP.il~1t1 If 7~a~/ M~~~~~~P:t:t I It~ '?P pMrJ,:~f..f,tl<;MtI /.P7~a~~\f..~~iA~'P:t:t I It~' !t.d.dMrJ,:~f..~t8MtI

SUSPENSION; ORAL ERYTHRCMYCIH ETHYLSUCCZHATE

AB HATL PHARM MFG/BARRE Eg ZOOMS BASE/SML * AB Eg 400MG BASE/SHLu

PEDXAMYCiH 400 AB ROSS LABS/ABBOTT Eg 400MG BASE/5ML

ERYTHROMYCIN STEARATE (PAGE 54)

TABLET; ORAL ERYTH~C~YC:r" ST=l~ATE

AS CHELSEA LABORATORIES Ed 250"'5 BASl:::! * EQ so,me; BASE IW Ipf..R"'t,:,pfi.'}j.~;~,:'f-/ IE i2S0[~a i~ASE!

ESTRADIOL CYPIONATE (PAGE 54)

INJECTABLE; INJECTION DE~O-ESTJ;!M!OL

AO UPJOHN 5MG/Hl 1NG/ML * 3NG/ML

ESTR~OICL CYF'J:ON~TE

AO CARTER-GLOGAU LABS SHG/~lLU

ESTRA~ruSTINE PHOSPHATE SODIUM (PAGE 55)

CAPSULE; ORAL EMCYT

HOFFMANN-LA ROCHE EQ 140MG PHOSPHATEu

ESTROGENS, CONJUGATED (PAGE 55)

TABLET; ORAL CONJUGATED ESTROGENS

BS CHELSEA LABORATO~IES O.625MGU * 1.25MG * 2.5MGU BS ZENITH LABORATORIES O.625MG * 1.25MG * 2.5MG

ETHINYL ESTRADIOL; ETHYNODIOL D!ACETATE (PAGE 56)

TABLET; ORAL-21 DHIULEN 1/35-21

SEARLE/SEARLE PHARMS O.035MG;lMGU

TABLET; ORAL-28 DEMULEN 1/35-28

SEARLE/SEARLE PHARMS O.035NG;lNGn

>...Q.1L> IETtlitNL 'ESTRAdioL; 'ETHYNcrltoL 'OiAUfATE; 'FER~d!Js 'FU~ARATE/ (PAGE 56)

>.JU:L> >...Q.1L> >...Q.1L>

1ff..~.Ltf';, 'PRf.t~#1 Ipttl.tJUtl,:'ft.:'.iN

I ~tf..ptt;#f..RU,' PHf..RM~/ p.:p<;MM;iMM.7<;tlrJ,!

ETHINYL ESTRADIOL; LEVONORGESTREL (PAGE 56)

TABLET; ORAL-21 NORDETTE

WYETH LABS/ANHO O.03NG;O.15MGU

Page 19: APPROVED PRESCRIPTION DRUG PRODUCTS

,""~'''''~''''

• DRUG PRODUCT LIST 1 CUMULATIVE S~NT NUMBER 12 / AUGUST '81 - AUGUST '82

>...!QJL> >...!QJL> > ADD >

ETHINYL ESTRADIOL; LEVONORGESTREL (PAGE 56)

TABLET; ORAL-28 NORDETTE-28

WYETH LABS/AMHO O.03MG;O.15MGIS

ETHINYL ESTRADIOL; NORETHI~~RONE (PAGE 56)

TABLET; ORAL-21 NORIHYL 1+35

AB SYNTEX (FP) O.035MG;lMG ORTHO-HOVL~ 1/35-21

AB ORTHO PHARMACEUTICAL O.03SMG;lMG ORTHO-NOVUM 10/11-21

ORTHO PHARMACEUTICAL O.035MG;0.5MG AND IMGIS

TABLET; ORAL-28 HtlR:!HYL 1+35

AB SYNTEX (FP) O.035MG;lMG ORTHO-HOVUM 1/35-28

AB ORTHO PHARMACEUTICAL O.035MS;lMG ORTHO-NOVUM 10/11-28

ORTHO PHARMACEUTICAL 0.035MG;O.5MG AND 1MGIS

FENFLURAMINE HYDROCHLORIDE (PAGE 58)

TABLET, CONTROLLED RELEASE; ORAL PONDIMIN

AH ROBINS 60MGIS

FLUNISOLIDE (PAGE 59)

AEROSOL; INHALATION/NASAL NASALIDE

SYNTEX LABS/SYNTEX 0.025MG/INHn:

FLUOCINOLONE ACETONIDE (PAGE 59)

AT AI

CREAM; TOPICAL FLUOCIMOLOHE ACETOH:!DE

CLAY-PARK LABS O.Ol?JS 3( O.02~/'1S

THAMES PHARMACAL ~IS 3( O.025?Jl

/¢tt.i. 'jppj.}!fitl

/ f 7~1g~~~i1~B~~J~~~~~~t~ P.: P~f>1./ GEL; TOPICAL

FLUONID HERBERT LABS/ALLERGN 0.025XJl

SOLUTION; TOPICAL FLUOCIHOLONE ACETOMIDE

AT NATL PHARM MFG/BARRE O.Ol?~

FLURANDRENOLIDE (PAGE 61)

LOTION; TOPICAL CORDRAH

AI DISTA PRODS/LILLY O.05? FLtlRAtIDREHOLI!l E

AT NATL PHARM MFGIBARRE ~IS

FOLIC ACID (PAGE 61)

TABLET; ORAL FOLl:C ACID

AA WESTERN RES LABS

FUROSEMIDE (PAGE 62)

INJECTABLE; INJECTION FUl(O!,;EMIDE

AP ABBOTT LABORATORIES AP LYPHO-MED AP PARKE-DAVIS/W-L AP WYETH LABS/AMHO

TABLET; ORAL

1MGJl

lOMG/MLJl 1011G/HLIS lON:3/MLt( lOIIS/MLIS

FVRO~F.M:!DE (SEE SPECIAL HOTE B) AS CHELSH LABORATORIES 201!GlI: 3( 40MGJ:I ~y,/ /}!PFP.·tA¢PRfi:fPF;tt~/ /mp.·f.-.·~.6M#/ AB CORD LABORATORIES 2CMG~ 3( 40!1Gt( AS LEDERLE LABS/AM CYAN 2CM~1S 3( 40HGn: AS MYLAN PHARMS' 20MGIS 3( 40MGIS

LASrx AB HOECHST-ROUSSEL 20MG 3( 4CMG

80NG

GALLIUM CITRATE, GA-67 (PAGE 62)

INJECTABLE; INJECTION GALLIUM CITRATE GA 67. /P;tf.¢NP~j;t}!.· j.~Pjppt~/ / f.tl}!j.)tltl

MEDI-PHYSICS IMCI/ML

GEMFIBROZIL (PAGE 62)

CAPSULE; ORAL LOPID

PARKE-DAVIS/W-L 200MGIS * 300NGn:

Page 20: APPROVED PRESCRIPTION DRUG PRODUCTS

DRUG PRODUCT LIST / CUMULATIVE SUPPLEMENT NUMBER 12 / AUGUST '81 - AUGUST '82 14

GENTAMICIN SULFATE (PAGE 62)

INJECTABLE; INJECTION GARAMYCJ:H

/~ J~~i~j~~/

AP SCHERING

HALAZEPAM (PAGE 64)

TABLET; ORAL PAXIPAM

SCHERING 20MG!!: * 40HG!!:

AP Eg 40 NS BASE/ML HALOPERIDOL (PAGE 64)

AP

AP

GENTAM!C:.m INTL MEDICATION SYS Eg lMG BASE/ML!!: * EQ 40MG BASE/ML

GENTAMJ:CIN SULFATE

lW CARTER-GLOGAU LABS Ed lOMG BASE/Ml!!: * Eg 40MG BASE/ML

/;ltlJt:tltp;l¢A1;lptl:~:YM IE '4d!c\G 'Eli.\slUi'lL/ AP AP

INVENEX LABS/DEXTER Eg 10MS BASE/I'lL!!: * Eg 40MG BASE/MLI:! KALAPHARM Eg 40MG BASE/~ll!!:

OINTMENT; TOPICAL GAIMMYCrH

AT SCHERING GEMTAM:tC:.m

AT CLAY-PARK LABS

GLYCOPYRROLATE (PAGE 63)

TABLET; ORAL -SL YCCPYRROLATE

AA DANBURY PHARMACAL

Eg lMG BASE/8M

Eg l~!G BASE/SHU

lMG~ * 2HG!!:

GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE (PAGE 63)

SOLUTION/DROPS; OPHTHALMIC > ADD > NEOMYC:.m SULFATE AND POLYMYXJ:H B SULFATE GR~,H:!c:m:!H >...MllL> AT PHARMAFAIR O.O?Eii~/ML;E:q 1.75HG BASF./NL; >...MllL> AT 5,000 l!NITF/~lL!!: >...MllL> 0.02S~lG/Ml;EQ 1.75MG BASE/ML; >...MllL> 10,000 UNITS/ML!!:

GRISEOFULVIN, ULTRAMICROCRYSTALLINE (PAGE 64)

TABLET; ORAL FULVICIN PIG 165

SCHERING FULVICIN PIG 330

SCHERING jFuLvtcIH':p)GI

FULVJ:CIH PIG

165MG!!:

330MG!!:

jGUAHEtHtdtNt'SULFAtt/(PAGE 64) GUANETHIDINE MONOSUlFATE (PAGE 64)

TABLET; ORAL HALDOL I r.¢tltti.' tA;3PRAJPR;ltM I,d,: ~ri0,'~,' .iM¢, 'f,' .it\);, , tf.' :;jl¢, '~,' .i,a MI

MCNEIL PHARM 0 .S~lG * ING * 2MG * 5MG '* 10MG * 20MGI:!

HEPARIN SODIUM (PAGE 6S)

INJECTABLE; INJECTION HEPARIN LOCK FLUSH

j MJ liNytiRx, jjlHfifhl~?tlp¢0t1idd 'lhttfs)HL/ AI' INVENEX LABS/DEXTER 10 l!N!TS/Mll:!: * 100 (!!!!TS/ML AI' WYETH LABS/AMHO 10 UH!TS/ML * 100 l[H!:T",lML

IM/ lW

AP AP AI' AP AP AP

HF.PARnf senIUM Jj~~%l#,'ftlfRM.S;M~0tli~6do 't!lfiTshIL ',*:5;000 'lh·\:ifs)HL 'fj

/1. ;dcid lhttrs}tiL/ INVENEX LABS/DEXTER 1,000 U~I:tT5/~lL * 5,ono UNITS/HL * SOLOPAK/MPL

10,000 l!NIiS/11L 1,000 UNITS/HL * 5,000 U~XTS/HL * 10,000 UHZTS/ML * 5. MO l'NITS/O. 511L:t lE

~Q ~3S0 U:i:r.TS/O. E:ll!!: IHEPA~:tH 'SeniUM ':ttl 'Hdrl~lA!.·~ d;~E/

1M.! ~g~~)j{tlHPl lid jd:HT~hll '~:itld 'u~~it$hjU IHEP~ ... I~:iRI

I AP/ Jj{RM0R:P~fiRJV li;rlco 'llrlzts)r.l( 'f.'rl;o6a 'ur1Il!i)ML 'f! lID lid~riaci 'dMfVHU

HEPARIN SODIUM; SODIUM CHLORIDE (PAGE 66)

INJECTABLE; INJECTION Ht;;PARIN !1"CllIU"! lono UN!TS ANn 5C)l)IlJM CHLO~IDE o.n !H

PLASTIC cnSTAINE'R AP TRAVENOl lABS 200 US:rTS/IOO'lL;~;;()()t1'3/10C'Ml!t

H!:PI':R:rn S(1!'lIUM zona l'NXTS AIm SOO!:U:1 CHLC~:;;P!: 0.9% IN PLASTIC COi1TAIPER

AP TRAVENOl LABS 200 rn{ITS/IO(!~L;~oc~;rc/lCCML~ HEPARIN SODIUM 5000 UNITS AND SODIUM CHLORIDE 0.9/0 IN

PLASTIC CotHAINER TRAVENOl LABS SOO UNITS/I00Ml;900MG/I00ML!!:

Page 21: APPROVED PRESCRIPTION DRUG PRODUCTS

• DRUG PRODUCT LIST / CUMULATIVE SUPPLEMENT NUMBER 12 / AUGUST '81 - AUGUST '82 15

HYALURONIDASE (PAGE 67)

INJECTABLE; INJECTION > DLT > IALtOASE > DLT >IW A .Lt:.p#Rtl~1 > DLT > IW)a~~~! > DLT >IW . . ~:.L.t.a~!Atl~pI

liso'uNtts}vtAL!

liso 'uNttsNtAl/ I ;i~.d. j0iUf~)tK j!., f..; ~9 9.' YN;tf~iY ;tAU > --illl..>

>~>

>~> >~>

WYDASE WYETH LABS/AMHO 150 UNITS/VIAL * 1,500 UNITS/VIAL *

150 UNITS/ML

HYDRALAZINE HYDROCHLORIDE (PAGE 67)

TABLET; ORAL

>.JllL> AA >~> AA

AA AA

HYDRALAZJ:HE HOL PREMO PHARM LABS LEMMON VANGARD LABS/MWM WESTERN RES LABS

25MGhf.'sOHG! 25MG * SONG 25m;J:l * 50/";GJ:l 25t1GJ:l * SOMGJ:l

HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE (PAGE 68)

CAPSULE; ORAL A~RESAZ:rnE

I.aPl 7¢j.~~;¢#A'~tj~:/1 It~r1~Jt~M.'f.'~.oMJ~.oM.'f.';i.o.ot1M~.or1M AB CIBA/CIBA GEIGY 25MG;2:'M13 * SOMS;SOMG * lOOMG;SOMG

HYIlRAl I.aPl 7mP.':.PRPYjptN:t.'.Lf..a~1 I#M.;t~MFi.'f.'~.of.M~.dtl~Fi.'f.';i.d.dr.~.;Mf.~FiI AB REID-PROVIDENT LABS 2S[IG;2S~!GJ:l * 50Hj;SOMGn * lCOMG;SOMGn

HYDRALAZJ:HE HOL ANn HYDROCHLCROT~rAZ!OE AB BOLAR PHARMACEUTICAL 2SHG;2S~lGJ:l * SOHG;SCNGJ:l * lOOMG;SOMSJ:l

HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINE (PAGE 68)

TABLET; ORAL HYDRAP-ES

BP PREMO PHARM LABS 25HG;15HG;O.IHGJ:l HYDROCHLOROTHIAZIDE/HYDRALAZINE HCL/RESERPINE

BP DANBURY PHARMACAL 25MGjI5MGjO.lMGJ:l R-HCTZ-H

BP LEDERLE LABS/AM CYAN 25MG;15MG;O.IHGU

HYDROCHLOROTHIAZIDE (PAGE 68)

TABLET; ORAL HYDRCCHLCROTH!AZ~nE

AB ASCOT HOSP PHARHS AS CORD LABORATORIES AB PRE~lO PHARM LABS AS PUREPACIKALIPHARM AS REID-PROVIDENT LABS AS VANGARD LABS/MWM AS WESTERN RES LABS

THJ:U~ETIC

AS PARKE-DAVIS/W-L Z:rnE

AB REID-PROVIDENT LABS

25M31:1 * 50tmu 2!H'lGI:I * SOM3 25MGlf * SaMG 2;::~ml:l * 5CMGl! 25!m!f.'sd~!a; 25MGU * SOM5J:l 25~!GU * SOMGI:t

2!iMGlI: * 50~!G)! SOM13

HYDROCHLOROTHIAZIDE; RESERPINE (PAGE 69)

TABLET; ORAL HYDROCHLOROTHIAZIDE W/ RESERPINE

1i/>P1 If~;tf.;tf~:RPt<ANt.'f.fir3$/ l#tls5.f.d.:;it~tl~:f:~.dtl~J.d.:;(2~MM BP ROXANE LABORATORIES 50~;O.125MG

HYDROCHLOROTHIAZIDE; SPIRONOLACTONE (PAGE 69)

TABLET; ORAL SP:;:~C:iOlACTO~r;:/HYD~OCl",lO~OTH:r.AZ:roE

AS DANBURY PHARMACAL 2St'G;2~~GU sprRC~OLACTONE W/ HYD~OCHLonOTH!:AZ:;:DE

AB LEDERLE LABS/AM CYAN 2:MG;25HGJ:l AB UPSHER-SHITH LABS 25HG;2:MGJ:l AS VANGARD LABS/HI~M 25M!:'; 2SMG::: AS WESTERN RES LABS 25~:G;2S~SU

HYDROCHLOROTHIAZIDE; TIHOLOL MALE.4TE (PAGE 69)

TABLET; ORAL TIMOLIDE

MS&D/MERCK 25MG;10MGD

HYDROCORTISONE (PAGE 69)

CREAN; TOPICAL FlEnCORT

AT WESTWOOD PHARMS KYD~OC(!~Tr~OHE

AT PHARHAFAIR AT TOWNE PAULSEN

O.5ZU * g!l: * 2.5"l.u

lZ%t 1075% 'Nl?

Page 22: APPROVED PRESCRIPTION DRUG PRODUCTS

DRUG PRODUCT LIST I CUMULATIVE SUPPLEMENT NUMBER 12 I AUGUST '81 - AUGUST '82 16

HYDROCORTISONE (PAGE 691

ENEMA; RECTAL /cc~ttNIfMA

/At! ~ktA~p~fi1p~jt$//idOMG)~dH(1 CORTENEMA

ROWELL LABORATORIES IOOMG/60ML /REctdrd!

/At! /PAfi~~fi¢jfiip~fi~~fi¢jfi//iddMG)~dM(!

AT

AT

>~>/At! > ADD> III >..A!llL>

LOTION; TOPICAL EPrCC!RT

BLULINE LABS 0.57.H:i:.?J HYDROCtlRTrSOHE

NATL PHARM MFGIBARRE ~" M 17." HUTRACORT /¢KEit ' tf..~$i fif.¢PN .• tA~$/ d : 5? • f.. 'W

OWEN LABSIDERM PRODS ~ M 17. 2.5/.1(

OINTMENT; TOPICAL HYDRCCORTISONE

AT SHAFFER-DAVIS LABS 0.5"1./ f.: W 17. AT THAMES PHARMACAL

POWDER; FOR RX COMPOUNDING H-CORT

AA PARAMEX LABORATORIES 1007." HYDROCORTZSOHE

AA PHARMA-TEK ~

TABLET; ORAL HYDROCORTISONE

/~p/ / $1 fiNf-/.~$i$j~p#/ tJ..dJ¥,: f.: ~.d~f,/ BP PUREPACIKALIPHARM IOMG * 20MG

HYDROCORTISONE; POLYMYXIN B SULFATE (PAGE 711

SOLUTION; OTIC OTOBroTZC

III SCHERINS ~;E9 10,000 UNITS BASEIML!l PYOCrOIH

III BERLEX/SCHERINS AS ~;lO,OOO UNITS/Nl

HYDROCORTISONE ACETATE (PAGE 711

CREAM; TOPICAL HYDROCORTISONE ACETATE

AT LIFE LABORATORIES 17.1( AT TOWNE PAULSEN (0:5-). 'N1?

HYDROCORTISONE BUTYRATE (PAGE 73)

CREAM; TOPICAL LOCOIO

GIST-BROCADES/NETH 0.1/,"

HYDROCORTISONE SODIUM SUCCINATE (PAGE 73)

INJECTABLE; INJECTION HYDRCCORTl:ECm£ SC'lIUM SI.'CCIl'IATE

AP CARTER-GLOGAU LABS Eg lON!G BASE/VIAL M

AP £9 250MG BAS~/VIAL * AP E9 50(l~'G BASE/V!AI.IS M

AP Eg IGM BASE/VT.ALIS AP INTL MEDICATION SYS E9 lOOHG BASE/VIAllS

HYDROXYZINE HYDROCHLORIDE (PAGE 741

INJECTABI.E; INJECTION HYDROXYZrHE HOL

AP BYK-GULDEN 25MG/HLI( M 50MG/Mll( 25MG/rlL!f M SC11GmLI:l 1SMG/HLIl M SOMG/MLI(

AP LYPHO-MED AP NATCON CHEMICAL

SYRUP; ORAL HYOROXYZ:tHE Hel

AA BAY LABORATORIES 10MG/SMUI lONG/SI1LJI AA KV PHARMACEUTICAL

TABLET; ORAL HYDROXYZINE HeL

AB PAR PHARMACEUTICAL lOMGI( M 25MGJI M ~JI

HYDROXYZINE PAMOATE (PAGE 74)

AB AB AB

>..A!llL> AB AB AB AB

> OLT >/MV >..AQ.!L> AB

AB AB

CAPSULE; ORAL HYDROXYZIW£ PAMOATE

BOLAR PHARMACEUTICAL EO 2SMG HCL!l M E9 SOMG HOlJl M Eg lO!)~IG HCll(

CHELSEA LABORATORIES Eg 2SHG HelJl M Eg SC~G HClu DANBURY PHARMACAL E9 SONG HCL~ M E9 l~r,~G HClU PAR PHARMACEUTICAL E9 2SMG HellS M EQ ~om; HelJl M

EQ lOOMG HelJl ZENITH LABORATORIES EGl 2St1G HelJl M EQ SO~!G HClJl

HY-PAN m:Etlp:p~#~:tA~$/ /E~ '2SM~ '~clli:!:tQ '5CMG 'wc(1i/

LEMMON EGI 2SMG HCll( M EGI 50!':G HelJl VZSTARJ:l

PFIZER LABS/PFIZER .m.....gSMG HCl M E9 SOMG HeL M Eg lOOMG Hel

Page 23: APPROVED PRESCRIPTION DRUG PRODUCTS

/ ,,~ • ~,;'

~--.... , • •~"

, ,

DRUG PRODUCT LIST I CUMULATIVE SUPPLEMENT NUMBER 12 I AUGUST '81 - AUGUST '82 17

IMIPRAMINE HYDROCHLORIDE (PAGE 75)

CONCENTRATE; ORAL IMIPRAMINE HCL

CIBA/CIBA-GEIGY

TABLET; ORAL IM:rPRA~NE HCL

AB VANGARD LABS/MWM AB WESTERN RES LABS

INDOMETHACIN (PAGE 7S)

25MGIMLJ(

~J( M SOMGJ( ~J(

CAPSULE, CONTROLLED RELEASE; ORAL INDOCIN SR

MS&D/MERCK 7SMGJ(

IODOXAMATE MEGLUMINE (PAGE 76)

INJECTABLE; INJECTION CHOLOVUE

ER SQUIBB AND SONS 9.9XJ( * 40.3XJ(

LEVOPROPOXYPHENE NAPSYLATE (PAGE 80)

CAPSULE; ORAL NOVRAD I f-f-t.' f:jUS I Itf!t· ~.dr1~:~#(· f..' tf!t' ;i.d.dr1~. 'r,fi#/

ELI LILLY INDSTRS/PR EQ SOMG BASE * EQ 100MG BASE

SUSPENSION; ORAL NOVRAD If-f:f-:tf.f-t:// /tf!t '~Ptl¢:~t$t;~r1f-1

ELI LILLY INDSTRS/PR EQ 50NG BASE/SML

LIDOCAINE (PAGE 80)

OINTMENT; TOPICAL LIDOCAINE

AT THAMES PHARMACAL g);!

LIDOCAINE HYDROCHLORIDE (PAGE 81)

IW AI'

IPODATE SODIUM (PAGE 77) I~

CAPSULE; ORAL >~> BILIVIST >~> AA BERLEX/SCHERING AG ~J(

ORAGRAr::m sonIUM >~> ~ ER SQUIBB AND SONS ~

ISOPROTERENOL HYDROCHLORIDE (PAGE 78)

SOLUTION; I~~ALATION ISOPROTERENOL HCL

AH DEY LABORATORIES ~J( AH INTL MEDICATION SYS ~J(

ISOTRETINOIN (PAGE 79)

CAPSULE; ORAL ACCUTANE

HOFFMANN-LA ROCHE

KANAMYCIN SULFATE (PAGE 79)

INJECTABLE; INJECTION KAHAMYC:m

SMGJ( * 10MGJ( * 40MGJ(

AP ELKINS-SINNIAHROBINS EQ 75MG BASE/2MLJ( * AP EQ SOCMG BASE/2MLU * Eg 1GM BASE/3MLJ(

SOLUTION; ORAL l!UnCAIHE MeL VISCOUS

AT INTL MEDICATION SYS 2%J( -- ILtdocAINE'VIsctus! --

XYLOCA!HE VI§CCUS

LINCOMYCIN HYDROCHLORIDE (PAGE 81)

I$;~~tl~~~~~~/ LINDANE (PAGE 82)

LOTION; TOPICAL IESCl.tJ:f.dU ~CABEHE

L:!:W1AHE

I tf!t· .z~.dr1~:j'§A$t;~r1f-1

AT NATL PHARM MFG/BARRE l%U

SHAMPOO; TOPICAL L:nmAtIE

AT NATL PHARM MFG/BARRE 12J(

;1

Page 24: APPROVED PRESCRIPTION DRUG PRODUCTS

DRUG PRODUCT LIST I CUMULATIVE SUPPLEMENT NUMBER 12 I AUGUST '81 - AUGUST '82

>...Q1L> >...Q1L> >....!illL> >....!illL>

LIOTHYRONINE SODIUM (PAGE 82)

TABLET; ORAL eYTCMEL

AB SK&F LABORATORIES BP

LIOTHYROHIHE SODIUM

Eg O.025MG BASE EQ O.OSMG BASE EQ O.OOSMG BASE

AB BOLAR PHARMACEUTICAL Eg O.025MG BASE~ BP EQ O.OSMG BASE~

LITHIUM CARBONATE (PAGE 82)

TABLET; ORAL L%TH%UM CARBOHATE

A8 ROXANE LABORATORIES 300MG~

TABLET. CONTROLLED RELEASE; ORAL ESKALITH CR

SK&F LABORATORIES 4S0MG~

MAGNESIUM CHLORIDE; POTASSTUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONAT~ (PAGE 84)

SOLUTION; IRRIGATION PHYSIOSOL IN PLASTIC CONTAINER

/ A~~p;f;f.· tf..~PFAjpFj.t$/ ~~~~~~71~~M1~~~~~~1~~Ai;jt\~);(d.dt\t.: I ABBOTT LABORATORIES 30MG/IOOMLi 37MG/IOOMLi 222MG/IOOMLi

S26MG/IOOMLiS02MG/IOOML

MAGNESIUM SULFATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE MONOBASIC; SODIUM CHLORIDE; SODIUM PHOSPHATE (PAGE 84)

SOLUTION; IRRIGATION TIS-U-SOL IN PLASTIC CONTAINER

TRAVENOL LABS 20MG/IOOML;40MG/IOOMLi6.2SMG/IOOMLi 800MG/IOOML;8.7SMG/IOOMLn

> ADD> MALATHION (PAGE 84)

> ADD > > ADD > > ADD>

LOTION i TOPICAL PRIODERM

PURDUE FREDERICK

MANNITOL (PAGE 84)

INJECTABLE; INJECTION MANHUOL 2S?

~ NATCON CHEMICAL

O.57.n

12.SGM/SOMLn

MAZINDOL (PAGE 85)

TABLET; ORAL MAZANOR.

BP WYETH LABS/AMHO IMG~ * 2MG SANOREX

I ~P1 I $fiNPpt: P~ARM)$fiNPPt~1~i~~ BP SANDOZ PHARMS/SANDOZ IMG * 2MG

MECLIZINE HYDROCHLORIDE (PAGE 85)

TABLETi ORAL MECLZZZt<E Hel

AA CHELSEA LABORATORIES 25MG~ AA VANGARD LABS/MWH 12.5MG~ * 2SMG~

MEPIVICAINE HYDROCHLORIDE (PAGE 87)

INJECTABLE; INJECTION I CAR:30C&:t!!E 'HO.!d

1M! /~#PN.'tfi#7.sftR~;iNM/i% '/<:W /rt,;'1

1m I ¢PPK.':j;l.4f.jt),SftRt;iN~/ / m

> ....!illL>

>....!!1:L> >....!!1:L> >....!!1:L>

CAR30CAWE BREON LABS/STERLING 17. * 1.57. * 27.

AP COOK-WAITE/STERLING ~%

MEPROBAMATE (PAGE 87)

TABLET; ORAL M;;:r::<C'.3A~'ATE

AA VA~GARD LABS/MWM AA WESTERN RES LABS

4(lOMG~

2(1C:1G~ ~ 40c!~1r;~

METHADONE HYDROCHLCRTDE (PAGE 90)

SOLUTION; ORAL METHADONE HCL

ROXANE LABORATORIES 5MG/5ML * lOMG/5ML~

METHANTHELINE BRomOE (PAGE 90)

Ij.N)t¢fA~tt.;. 'j.tl)t¢jjPtV /.s;\Nj~;tNti

I $tARU)$tfiptt.' p~f.Rt\N ~,dt\~;Yj.AtI METHAMPHETAMINE HYDROCHLORIDE (PAGE 90)

TABLET; ORAL Mnft~l;nfnAH:;:N~ Nel

AA LEM~lON SM~ll

18

Page 25: APPROVED PRESCRIPTION DRUG PRODUCTS

,-.~

DRUG PRODUCT LIST / CUMULATIVE SUPPLEMENT NUr.BER 12 / AUGUST '81 - AUGUST '82

METHDILAZINE (PAGE 91)

TABLET, CHEWABLE; ORAL TACARYL

WESTWOOD PHARHS 3.6MG

METHDILAZINE HYDROCHLORIDE (PAGE 91)

If A~~~~k~l~t~A~tt.i.' PRAU I. l~t.sj~PPP:.PtlARtlM tJ.:f,tlM

METHOCARBAMOL (PAGE 91)

AA AA AA AA

TABLET; ORAL METHOCARBAMOl

LEDERLE LABS/AM CYAN SOOMG * ~ PREMO PHARM LABS SOOMG!!: * 750HG!!: SUPERPHARM ~!!: * 750HG!!: UPSHER-SMITH LABS ~!!: * 750HG!!:

METHOXSALEN (PAGE 92)

1M! BP

1M! BP

CAPSULE; ORAL METHOXSALEN (SEE SPECIAL NOTE C) I ¢PRP.' U~PRAjpR;tt.s1 I idt4Gil.1

CORD LABORATORIES 'lOMG!!: OXSORALEN (SEE SPECIAL NOTE C)

~~~~~~~~~~~~~~ ~i~~~~ ELDER PAHRMS 10MG

LOTION; TOPICAL OXSORALEN I.PA!)f-:~:tf-ptRI

ELDER PHARMS /f:i.1

IX

METHYCLOTHIAZIDE (PAGE 92)

TABLET; ORAL ENDURON

1f!,P! I Af!,f!,pjj. 'tAf!,PRAjPR;tt.s1 ~~~~~M AB ABBOTT LABORATORIES 2.5MG * 5HG

METHYCLOTHIAZIDE AB BOLAR PHARMACEUTICAL 2.5MG!!: * ~!!:

> ADO > AB MYLAN PHARMS ~!f * 5HG!!: AB ZENITH LABORATORIES 2.5MG!!: * 5MG!f

METHYLDOPA (PAGE 93)

SUSPENSION; ORAL ALDOMET

MS&DIMERCK 2S0MG/SML!!:

METHYLPHENIDATE HYDROCHLORIDE (PAGE 93)

TABLET, CONTROLLED RELEASE; ORAL RITALIN-SR

CIBA/CIBA-GEIGY 20MG!!:

METHYLPREDNISOLONE (PAGE 93)

AS

BP I@}

BP

TABLET; ORAL MEUROl

UPJOHN

METHYLPREDNISOLONE

4MG * 16~!G 2MG * 8MG * 24MG * 32NG

CHELSEA LABORATORIES 4NG!!: * 16MG!!: IPRtt1P.'.PtlARtI.'UJ3~1 14p.G/

PREMO PHARM LABS 4~lG

METHYLPREDNISOLONE ACETATE (PAGE 93)

INJECTABLE; INJECTION METHYLPREDNISOLONE ACETATE

BP LEMNON 20MG/ML!!: * 80MG/ML!!:

METHYLPREDNISOLONE SODIUM SUCCINATE (PAGE 94)

INJECTABLE; INJECTION ME,HYLPR~DNZSOLCNE

AFt ORGANON E(J 5!!C~G BA!;E/VJ:AI.!f * EQ It::tl B,AS'UVIAL!!: AFt

METHYLPRE!WIS!lLCNE son:r.tm S1J~C~NATE AP CARTER-GLOGAU LABS EQ 4C~lG BASE/VrAL!!: * AP EQ 125~GBASE/V:rAL~

METHYLTESTOSTERONE (PAGE 94)

TABLET; BUCCAL/SUBLINGUAL METHYLTESTOSTERONE

1~.pI l.sjA~tAf!,.s!.sjtlPAKI Ijptl~1

TABLET; ORAL METHYLTESTOSTERONE

I~pl l.sjA~tA~.sI.sjM.pfiKI jj.Or1~. 'f. 'jt:it1¢1

19

Page 26: APPROVED PRESCRIPTION DRUG PRODUCTS

DRUG PRODUCT LIST / CUMULATIVE SUPPLEMENT HUMBER 12 / AUGUST '81 - AUGUST '82

METOCLOPRAMIDE HYDROCHLORIDE (PAGE 9S)

INJECTABLE; INJECTION REGLAN 1 ,(~. 'F~t!;t~f,1 itA ';(dtl¢. 't!,(f,f./ttlf-l

AH ROBINS EQ SMG BASEIML

METRONIDAZOLE (PAGE 9S)

AP

AP

INJECTABLE; INJECTION FLAGYL I.V. RTU

SEARLE PH ARMS 500MG/IOOML FLAGYL I.V. RTU IN PLASTIC CONTAINER

SEARLE PHARMS SOOMG/IOOMLU >...Mm....> >...Mm....> AP

METRO I.V. AM MCGAW/AM HOSP 500MG/IOOMLU

TABLET; ORAL FLAGYL

IW ~tf./f,f.'(Ftf.. '.p~'(Ftlf,1 j~~t\il I .. 1

>...AQJL> >...AQJL> >...AQJL>

AS

AS AS

SEARLE/SEARLE PHARMS ~ M SOOMG METROHIDAZOLE

LEMNON 250MGU ZENITH LABORATORIES 250MGU M SOOMGU

MEZLOCILLIN SODIUM MONOHYDRATE (PAGE 96)

INJECTABLE; INJECTION MEZLIN

MILES PHARMS/MILES EQ IGM BASE/vIALu * EQ 2GM BASE/vIALu * EQ 3GM BASE/vIAL~ * EQ 4GM BASE/VIAL~

MICONAZOLE NITRATE (PAGE 96)

CREAM; VAGINAL /tlp~;tf,jl.f,':'jf

MONISTAT 7

SUPPOSITORY; VAGINAL MONISTAT 7 .

OR THO PHARMACEUTICAL lOOMG~

MINOCYCLINE HYDROCHLORIDE (PAGE 96)

TABLET; ORAL MINOCIN

LEDERLE LABS/AM CYAN EQ SONG BASE~ * EQ lOOMG BASE~

MOXALACTAM DISODIUM (PAGE 96)

INJECTABLE; INJECTION MOXAM

ELI LILLY EQ 2S0MG BASE/VIALu * EQ 500MG BASE/vIALU * EQ IGM BASE/VIALu * EQ 2GM BASE/VIALu * EQ 106M BASE/VIALu

NANDROLONE PHENPROPIONATE (PAGE 97)

INJECTABLE; INJECTION DURABOLIN

ORGANON/AKZONA DURABOLIN-50

ORGANON/AKZONA

NAFCILLIN SODIUM (PAGE 97)

25MG/ML

50MGIML

CAPSULE; ORAL IHALL~W

1M! ~ttrAtl:.LA~~;~tf.¢~Atl/EG 'i5d~G 'BASE/ UNIPEN

lAM Irl.ytj~:U¢~!JJ1MI lEg '256MG 'fl.~stl WYETH LABS/AMHO EQ 250MG BASE

TABLET; ORAL I,U((pF-H!

I AM l~iUi4Atl. '.LJ¢~!J3tf.¢~fitlltg '5d;:\~IG 'BAsE! UNIPEN

I MY ljol:ttj~. '.Lfi¢~/.LtlMI lEd '5d~~ls 'BASEl WYETH LABS/AMHO EQ 500MG BASE

NAPHAZDLINE HYDROCHLORIDE (PAGE 97)

SOLUTION/DROPS; OPHTHALMIC Ml~O·S OPCOH

AT HURD PHARMACEUTICAL O.l?~

IHEG4TO(I(PAGE 98)

I f,~.L~:t;t~tU. ':t~.P;t¢J.L.;. 'Y fi¢;ttlfi.Li ItlEdATAHI

l#'}f#.' .L'(~f,/¢1jl.;¢f.p~1 1+'/>-;'1

20

Page 27: APPROVED PRESCRIPTION DRUG PRODUCTS

., ~-DRUG PRODUCT LIST / CUMULATIVE SUPPLEMENT NUMBER 12 / AUGUST '81 - AUGUST '82 21

NEOMYCIN SULFATE (PAGE 98)

POWDER; FOR RX COMPOUNDING HEO-RX

I~ ~Mfi~jtKI Itt' iddG~:Mj~~~1~ '~9. '~,d~M:~fi#/i3p;t / Ii. 'Ii.d¢i'l. ~fi$ .. , , F. AA

I~ AA AA

/W AA

PHARMA-TEK HEOMYCrH SULFATE

~

IttKjN~;$j~9Vfi~~p~j~~/tQ'iddGM'BASE)BdTI ELKINS-SINN/AHROBINS 100? PADDOCK LABORATORIES 100?,~

/pp)p~~/ l~ddGM'BASt)BdT/ UPJOHN 100?

NIACIN (PAGE 99)

TABLET; ORAL H!ACIH

I ~ 7JYr)l~tt. 'tl¢$/fiM, '¢'JfitVsddMG!

NICLOSAMIDE (PAGE 99)

TABLET, CHEWABLE; ORAL NICLOCIDE

MILES PHARMS/MILES 500MG~

NIFEDIPINE (PAGE 99)

CAPSULE; ORAL PROCARDIA

PFIZER LABS/PFIZER 10MG~

NITROGLYCERIN (PAGE 100)

INJECTABLE; INJECTION NITRO-Brn

AP MARION LABORATORIES 5MG/ML~

HrTROGLYCERrH AP ABBOTT LABORATORIES SMG/ML~

NITROSTAT WARNER-LAMBERT 0.8MG/ML~

TR!DJ:L AP AM CRITICAL CARE/AHS ~~

NORETHINDRONE ACETATE (PAGE 100)

AS

AS

TABLET; ORAL AYGESTrH

AYERST LABS/ANHO HCRLUTATE

PARKE-DAVIS/W-L/PR

5MG~

SMG

NYSTATIN (PAGE 101)

CREAM; TOPICAL MYK:!NAC

AI NNC LABORATORIES 100,000 UHrTS/G~

SUSPENSION; ORAL HYSTAnN

AA NATL PHARM MFG/BARRE 100,000 mfrTS/ML~

ORPHENADRINE CITRATE (PAGE 101)

TABLET, CONTROLLED RELEASE; ORAL H~~FLEX

/i3¢1 J##t#:tl¢$/.3tV /f..d,or.,;/ AB

AS

RIKER LABS/3M CRFH~ADR!HE CITRATE

lOO!1G

BOLAR PHARMACEUTICAL 10CMG~

OXTRIPHYLLINE (PAGE 102)

TABLET, CONTROLLED RELEASE; ORAL CHOLEDYl SA

PARKE-DAVIS/W-L 600MGn

PENTAZOCINE HYDROCHLORIDE (PAGE 107)

TABLET; ORAL /;f J.trAjtV

TALWII-I 50

PENTETATE INDIUM DISODIUM, IN III (PAGE 108)

INJECTABLE; INJECTION MPI INDIUM DTPA IN III

MEDI-PHYSICS 1MCI/ML~

PENTOBARBITAL SODIUM (PAGE 108)

SUPPOSITORY; RECTAL NEMBUTAL

ABBOTT LABORATORIES 30MGn * 60MGU * 120MG~ * 200HG~

PHENOIMETRAZINE TARTRATE (PAGE 109)

> -.illl. > / MI > AOD > At.

CAPSULE; ORAL PHEH'ZM~TRAzrNE T~RTRATE

l¢pp~.jt#il#jpjUdl l~sMrJl REID-PROVIDENT LABS 35M3

Page 28: APPROVED PRESCRIPTION DRUG PRODUCTS

DRUG PRODUCT LIST / CUMULATIVE SUPPLEMENT NUMBER 12 / AUGUST '81 - AUGUST '82 22

PHENDIMETRAZINE TARTRATE (PAGE 109)

CAPSULE, CONTROLLED RELEASE; ORAL PHENDIMETRAZINE TARTRATE

BC CORD LABORATORIES 105MG~

BC DM GRAHAM LABS 105MG~

BC VITARINE/WEST CHEN 105MG > ADD > X-TROZINE L.A. >~> BC REXAR PHARMACAL 105MGU

TABLET; ORAL MEmA

1M/ -,p;ijF.'#;¢~RprV.t.t.pjl 135~lrj/ AA

AA

ONEAL JONES&FELDMAN 35MG X-T~OZ:rH:

REXAR PHARMACAL 35MG~

PHENTERMINE HYDROCHLORIDE (PAGE 110)

CAPSULE; ORAL OBY-TRIM

AA REXAR PHARMACAL 30MGU PHEHTE'RMIME HCl

AA WESTERN RES LABS 30MGU

TABLET; ORAL PH!!HTERM:rHE' HCl

>..JlJl>IM/ 7¢i\rp. 't.#ifrAf.iPRf.f.$1 ItMG/ >~> IQM >~>AA REID-PROVIDENT LABS ~

PHENYLBUTAZONE (PAGE Ill)

CAPSULE; ORAL AZOUD

AB USV PHARMACEUTICAL lOOMG~

BUTAZOl:m:rH AB GEIGY/CIBA-GEIGY ~u

PHEHYLBUTAZONE AD CORD LABORATORIES lOOMG~

TABLET; ORAL PHF.HYlBUTAZOHE

AB DANBURY PHARMACAL lOOMGU

PIPERACILLIN SODIUM (PAGE 112)

INJECTABLE; INJECTION PIPRACIL

LEDERLE PIPERACILLIN EQ 2GM BASE/VIALU * EQ 3GM BASE/VIAL~ * EQ 4GM BASE/VIAL~

PIROXICAM (PAGE 1121

CAPSULE; ORAL FELDENE

PFIZER LABS/PFIZER 10HG~ * 20HG~

POTASSIUM CHLORIDE (PAGE 113)

INJECTABLE; INJECTION PCTA!"SZUM CHLORIDE

AP LEMMON

PRAZEPAH (PAGE 115)

CAPSULE; ORAL CENTRAX

PARKE-DAVIS/W-L

2Msg/ML~ * 3HEC/ML~

5MG * 10MG * 20MGn

PREDNISOLONE ACETATE i SULFACETAMIDE SODIUM (PAGE 116)

SUSPENSION/DROPS; OPHTHALMIC BLEPHAMIDE

ALLERGAN PHARMS O.2r.;10r.u

PREDNISONE (PAGE 116)

SYRUP; ORAL LIQUID PRED

MURD PHARMACEUTICAL 5MG/5MLn

TABLET; ORAL

I t3X/ .P7~~;~~1~'PRAjPR;tt$1 I ~ti~1 PREDNISONE

BX CHELSEA LABORATORIES 5MG ,. 10MG:! * 20MG * 50~lGn BX 1.p~;t.L;t.p,S, 'RPXANt.'t.J#IIt>M¢.'fc, ';(dt1¢, ·fc.'t,dM.'l '~,6M/ BX ROXANE LABORATORIES IMGn * 2.5MG~ * 5MG * 10MG * 20MG * BX SONG

BX BX

UPSHER-SHITH LABS VANGARD LABS/MWM

PR08ENECID (PAGE 118)

TABLET; ORAL I'>10BEHr:C:rn

25HGn 5MGIl * 20MGIl 5HGIl * 20MGn

>~>/~ ~{KA~t.At3$;t3tt¢HtM/56~MG(

Page 29: APPROVED PRESCRIPTION DRUG PRODUCTS

• ,

f:;-;-= ..

DRUG PRODUCT LIST / CUMULATIVE SUPPLEMENT NUMBER 12 / AUGUST '81 - AUGUST '82 23

PROCAINAMIDE HYDROCHLORIDE (PAGE 1181

AB lID

AB

AB

AI'

AI'

CAPSULE; ORAL P~OCAI:HAM:!DE HCL

ASCOT HOSP PHARMS IPARKt;PAyj~;~;tl

VANGARD LABS/MloIH P~CCAH

PARKE-DAVIS/W-L

INJECTABLE; INJECTION PRCCAI:HAMI:DE HeL

CARTER-GLOGAU LABS PRONESTYl

ER SQUIBB AND SONS

250HGlf IE SOOHG!l lisd,'la'~:~

250MGlf IE 50mlGlf

~ IE 375MGI:t IE 500HG

lOOHG/Mllf IE SOOHG/MLlf

lOOHG/Hl IE SOOMG/ML

TABLET, CONTROLLED RELEASE; ORAL IPRPS:f.tV

PROCAN SR BC PARKE-DAVISIW-L 500MG

250MG IE 750MGlf PRONESTYL-SR

BC ER SQUIBB AND SONS 500MGlf

PROCHLORPERAZINE EDISYLATE (PAGE 1191

CONCENTRATE; ORAL COMPAZI:HE

AA SK&F LABORATORIES E9 lOMG BASE/ML PROCHlORPERAZI:HE

AA NATL PHARM MFG/BARRE E9 lOMG BASE/Mllf

PROMETHAZINE HYDROCHLORIDE (PAGE 1201

SUPPOSITORY; RECTAL PHENERGAN

BR WYETH LABS/ANHO 25NG IE 50NG 12.5MG

PROMETHACON BR ALCON LABORATORIES 25NGlf IE 50NGlf

SYRUP; ORAL P~OMETHAZ:mE HCl

AA PHARNS ASSOC/BEACH 6.2SMG/SMllf

PROPANTHELINE BROMIDE (PAGE 1201

If?~,!~~~~~~~~~~~~~~:~~:;~:;~:~Atl

PROPARACAINE HYDROCHLORIDE (PAGE 1211

SOLUTION/DROPS; OPHTHALMIC >~> PA~ACA!NE

>~> AT PRO PHARMA/STERI-MED O.Sr.~

PROPOXYPHENE HYDROCHLORIDE (PAGE 1211

1M! At:.

> ...J2.JJ...->1 W >~>AA

CAPSULE; ORAL DAI<VCN 7Rf:tH-t11 1!2~lG 'r:6Sr1G/

ELI LILLY INDSTRS/PR 32M3 IE ~ PROPOXYPHE:iE Mel jJlFiM.' .pHMi\, .LA~~I I 65HG/

LEMMON ~

PROTEIN HYDROLYSATE (PAGE 1221

INJECTABLE; INJECTION AMIGEN

MEAD JOHNSON/B-M 5r.

PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROL!DINE HYDROCHLORIDE (PAGE 1221

SYRUP; ORAL ACTIFED

BURROUGHS WELLCOME 30MG/5ML;1.25MG/5ML

TABLET; ORAL ACTIFED

BURROUGHS WELLCOME 60MG;2.5MG

PYRIMETHAMINE; SULFADOXINE (PAGE 1231

TABLET; ORAL FANSIDAR

HOFFMANN-LA ROCHE 25MG;500MGlf

QUINIDINE GLUCONATE (PAGE 1241

TABLET, CONTROLLED RELEASE; ORAL QU:::NAG!.UTE

AS BERLEX/SCHERING AG ~ gu:m:rl):n!E GLUCC~'!ATE

~ BOLAR PHARMACEUTICAL 324HGlf

Page 30: APPROVED PRESCRIPTION DRUG PRODUCTS

DRUG PRODUCT LIST / CUMULATIVE SUPPLEMENT NUMBER 12 / AU.GUST '81 - AUGUST '82

QUINIDINE SULFATE (PAGE 124)

1M! AB AB AB

TABLET; ORAL GUZH!DrHE SULFATE Ntxfitt.'PFJW

REXAll VANGARD LABS/MWM WESTERN RES LABS

IzddMSI 200MS 200MSlS 200MGIS

RAUWOLFIA SERPENTINA (PAGE 124)

TABLET; ORAL lj1.fiUTPTfif-1

It!>pl /p~j.'f:j.P$:#.fJ,#Nt:t.fit!>$/ /!>pfflf,/ RAUWOLFIA SERPENTINA

1t!>P1 /Pttt.L;ip$, 'j1.fJ,#Nt, '.LAt!>$/ /f.,d,dfflf,/

/t!>P//j1.~~~~~~:'p~fi#'Mfi¢tPj;i¢A.L/JPpM~/

RESERPINE (PAG~ 125)

TABLET; ORAL RAURINE

1t!>P1 1¢)tf!¢~#'(JMfif-.Lpj/ l,d,:tt>M~:/ BP ONEAL JONES&FELDMAN 0.25MG

RESERPINE It!>p/ /Mfif-.LA#'~/ l.d.:t!>MM

SAFFLOWER OIL (PAGE 126)

INJECTABLE; INJECTION LIPOSYN 20;1.

ABBOTT LABORATORIES 20;l.n

SECOBARBITAL SODIUM (PAGE 127)

CAPSULE; ORAL SEC08ARBZTAL SODIUM

AA ICN PHARMACEUTICALS ~lS

SELENIUM SULFIDE (PAGE 127)

LOTION/SHAMPOO; TOPICAL l:tdsEL'Zf.dl

I M.I N#it 't#$/ fi.L¢(J~. '.L#$I z: til SELENnlM SULF!DE

AT THAMES PHARMACAL ~IS

SELENOMETHIONINE, SE-75 (PAGE 127)

INJECTABLE; INJECTION . SELrrntlMETH7.m.fl:~m SF- 75

I W /J3.tfi¢i{d$f#,'j3pjr;:JPi.$/ I ~5d 'uctJMLI AP MEDI-PHYSICS 250 UCUHL

SILVER SULFADIAZINE (PAGE 127)

CREAM; TOPICAL SrLVADENE

AT MARION LABORATORIES 1% SrLVER SULF~nrAZrHE

AT TRAVENOL LABS 17.lS

SODIUM CHLORIDE (PAGE 128)

INJECTABLE; INJECTION SOI)n1M C~!,CRrDE

"> ...m;L">/W /~0JfiR,JtA~PRAf¢R;it$/ /zOGMJidoML/

SODIUM IODIDE, 1-123 (PAGE 130)

CAPSULE; ORAL SODIUM IrO!DE I 123

AA BENEDICT NUCLR PHARM 100 UCI~ 200 UCln * 400 UCIlS

AA MEDI-PHYSICS 100 UCZ

SODIUM IODIDE, 1-131 (PAGE 130)

CAPSULE; ORAL SODIUM IODIDE I 131 1¢;i$:#.AP;ipp)iARtl$/ 1!>,d:p¢;i:I<:J,d,d:p¢;tj

SYNCOR INTL 50 UCI * 100 UCI

SODIUM NITROPRUSSIDE (PAGE 130)

INJECTABLE; INJECTION HII'RIDE

AP HOFFMANN-LA ROCHE 50MG/VZAL HJ:TROI'RESS

AP ABBOTT LABORATORIES 50MG/VIALn SODIUM HITROrR!JSS!:DE

AP ELKINS-SINN/AHROBINS 50MG/vZAllS

SODIUM PERTECHNETATE, TC-99M (PAGE 130)

SOLUTION; INJECTION, ORAL SODIUM PERTECHNETATE TC 99M / ¢j'f>, 'RAPjpptlARtlM jj:J.tl¢;iltl.L. '1<,' jffr1¢;tltl.L. '!.'

SYNCOR INTL 12MCI/ML * 24MCI/Ml *

24

Page 31: APPROVED PRESCRIPTION DRUG PRODUCTS

SOYBEAN OIL (PAGE 131)

INJECTABLE; INJECTION IHTRALIPID 10?

DRUG PRODUCT LIST / CUMULATIVE SUPP

Af CUTTER LABORATORIES 10? TRAVAMULSIOH 10?

AP TRAVENOL LABS ~~

SPIRONOLACTONE (PAGE 131)

TABLET; ORAL SPIROHOLACTOHE

AB LEDERLE LABS/AM CYAN 25MG~ AB UPSHER-SMITH LABS 25MG~

AB VANGARD LABSIMWM 25MG~

STREPTOZOCIN (PAGE 132)

INJECTABLE; INJECTION ZANOSAR

UPJOHN

/succtHYLc~dLtHE/(PAGE 132)

IGMIVIAL~

/j~~~~~~~~~!.~:~:~;~:~~~//~~M¢;MtI SUCCINYLCHOLINE CHLORIDE (PAGE 132)

INJECTABLE; INJECTION SUCCINYLCHOLINE CHLORIDE

INTL MEDICATION SYS 100MGIVIAL~

SUCRALFATE (PAGE 132)

TABLET; ORAL CARAFATE

MARION LABORATORIES IG~

SULFABENZAMIDE; SULFACETAMIDE; SULFATHIAZOLE; UREA (PAGE 132)

CREAM; VAGINAL TRIPLE SULFA

AT PHARMADERMlBYK-GULDN!.TI.;~;!.42?';0.64?~

12 / AUGUST '81 - AUGUST '82

SULFAMETHIZOLE (PAGE 133)

/$~~,~j~~~~;;:::~~fittPj/ /~ppM¢!~nt/ /PN.E#:,JPN.E#,F.EtpMfiN/ /~.o.oM¢8MtI

/~ AS

TABLET; ORAL MICROSUL /P,Jfo,F.'#!¢t4#pMfi,Ltpj/ /'J.¢rV

ONEAL JONES&FELDMAN IGM PROKLA~

/i5)U.'#!¢t4RPMfiUpj/ /SOOMG! ONEAL JONES&FELDMAN scaMS

SULFAMETHOXAZOLEi TRIMETHOPRIM (PAGE 133)

TABLET; ORAL SULFAMETHOXAZOLE AtlD TR:IMETH~J:!RrM

AS LEMMON 40~H~;8Cl~~~

25

SULFAMETtiOXAZOLE AND TR:IH!::TH:'Pr;>T.H MOOLE STREHGTH AS LEMMON 800HS;16CMG~

SULFINPYRAZONE (PAGE 134)

TABLET; ORAL AHTUlMt-!E

AB CIBA/CIBA-GEIGY lOONS SULF:IHI'YRA'lOHE

AB DANBURY PHARMACAL lOaMG~ AS ZENITH LABORATORIES lCOMG~

TECHNETIUM, TC-99M, DISOFEN!N KIT (PAGE 136)

INJECTABLE; INJECTION HEPATOLITE

MED DIAG/NE NUCLEAR N/A

TECHNETIUM, TC-99M, ETIDRONATE KIT (PAGE 136)

INJECTABLE; INJECTION

/M! TECHHETIUM TC 99M D:IPHOS~!fl)H!\TE-T:tH I<:IT !iUMNagjj¢' , .t$3JPJlt{ 'lim!

AP MEDI-PHYSICS H/A

TECHNETIUM, TC-99M, GLUCEPTATE KIT (PAGE 136)

INJECTABLE; INJECTION Gl.u~n5CAIi

AP MED DIAG/NE NUCLEAR N/A - TECHNF.SCAH GLUCEPTATE -AP MS&D/MERCK H/A~

Page 32: APPROVED PRESCRIPTION DRUG PRODUCTS

DRUG PRODUCT LIST / CUMULATIVE SUPPLEMENT NUMBER 12 / AUGUST '81 - AUGUST '82

>...!Q!L>

TECHNETIUM, TC-99M, MEDRONATE KIT (PAGE 136)

INJECTABLE; INJECTION AMERSCAH

> ADD > AP AMERSHAMIRADIOCHEM H/A~

MllP K::tT IW /~j.#t\p~jj.¢:j.~Pfpp'l.'f.1 ItVA/

AP MEDI-PHYSICS H/A

TECHNETIUM. TC-99M2 PENTETATE KIT (PAGE 136)

INJECTABLE; INJECTION DTPA ~SH~ KIT (CHELATE)

IW /j)j.fd~P f#:j.~Pfppt~lltVA/ AP MEDI-PHYSICS H/A

RENOTEC IJS~I nR.'i!~j.JSJS:AM5:~p~$1 I~!AI AP ER SQUIBB AND SONS MIA - TECHNETIUM TC 99M OTPA ~ KIT

I ill 7?-#. 'RA~j.pjl~MI'\iV 7 A

>.JllL>

AP SYNCOR INTL H/A

TECHNETIUM, TC-99M, POLYPHOSPHATE KIT (PAGE 137)

INJECTABLE; INJECTION SODIUM POLY PHOSPHATE-TIN KIT lr'rj.A~NP~jj.¢.' j.~pjppt~1 IN! fi./

MEDI-PHYSICS N/A

TECHNETIUM. TC-99M2 SUCCIMER KIT (PAGE 137)

INJECTABLE; INJECTION MPI DMSA KIDNEY REAGENT

MEDI-PHYSICS N/A~

TECHNETIUM, TC-99M. SULFUR COLLOID (PA~E 137)

INJECTABLE; INJECTION TECHNETIUM TC 99M SULFUR COLLOID

~~9~~~~~~~~~1~~~1 ~~~2~~~i~

TERBUTALINE SULFATE (PAGE 137)

INJECTABLE; INJECTION BRETHiHE

A! GEIGY/CIBA-GEIGY BRJ:CAHYL

A! ASTRA PHARM PRODS

lMG/MLJ(

~

TETRACYCLINE (PAGE 138)

leg 'i25t~d 'HC(}SI,h:1

TETRACYCLINE HYDROCHLORIDE (PAGE 138)

CAPSULE; ORAL TETRACYCLINE HCL

AB DANBURY PHAR~IACAL 250!o!Gl:l * 50CMGl:l

THEOPHYLLINE (PAGE 1391

CAPSULE. CONTROLLED RELEASE; ORAL S0!10PHYlLIN-CRT Ift~PN~/ /;t#tl~P. 'f.. '.i~,6fl~p/

Be FISONS 250MGl:l

BC

BC

BC

SLO-PHYlLIN WILLIAM H RORER

THEOCLEAR LA-l30 CENTRAL PHARMS

THEOCLEAR LA-260 CENTRAL PHARMS

THEOPHYLLINE VITARINE

ELIXIR; ORAL THEOPHYl 225

lOOHGI:S

250MG!I 60MGl:l * 125HGlI

l30HGlS

260MGlS

260MGl%

KNOLL PHARMACEUTICAL 112.5MG/15ML~ THr::OI'HYLL:tHl:

AA LIFE LABORATORIES 8nMG/1~MLI:S

AA PHILIPS ROXANE LABS 8Cr-:~/15f!L!!

aOMG/1SML Tt'!l!OCCLEAR-80

1M! IUN1Rfi( 'jl~fiRtlAcAti I ad!,)1):{SMLlij AA CENTRAL PHARMS 8C~lS/lE~IL!I:

TtlF.C?I1YLL!NE AA NATL PHARM MFG/BARRE 8C'M3/15HL!!

TABLET; ORAL SLO-PHYLLIN

150MG/15MLr:I

> ~> I'f,pl IppPtltR:~fpPR,(fpRtt~! 1;(6.6tl~:f..'.i,6,6~M >~> BD WILLIAM H RORER 100MG *200MG

26

Page 33: APPROVED PRESCRIPTION DRUG PRODUCTS

THEOPHYLLINE (PAGE 139)

TABLET; ORAL THEOCLEAR-I00

/f,p! /¢t~f,#fif-:ptlfi,#Mf.¢fiti BD CENTRAL PH ARMS

THEOCLEAR-200 ! f!p/ I ¢t~;t,#fif-. . ptlfi'#MficA L

BD CENTRAL PH ARMS

TIMOLOL MALEATE (PAGE 142)

TABLET; ORAL BLOCADREN

DRUG PRODUCT LIST I CUMULATIVE

/f.ppM~! lOOMG

/.2.d.dM~/ 200MG

MS&D/MERCK 10MG~ * 20MG~

TOBRAMYCIN (PAGE 142)

OINTMENT; OPHTHALMIC TOBREX

ALCON LABORATORIES O.3X~

TOLBUTAMIDE (PAGE 142)

TABLET; ORAL TOLBUTAM:tDE

!§ VANGARD LABS/MWM 500MG~

TRAZODONE HYDROCHLORIDE (PAGE 142)

TABLET; ORAL DESYREl

MEAD JOHNSONIB-M 50MG~ * 100MG~

TRIAMCINOLONE ACETONIDE (PAGE 143)

AT

AI

> ADD > AT -/Ail

AI

CREAM; TOPICAL ~

NMC LABORATORIES 0.02~~ M ~~ TRIACOI?T

ROWELL LABORATORIES O.l?~ TRIAMCINOLONE ACETOHIDE

PHARMAFAIR 0.025'~ M O.lr.~ M 0.5r.~ /$tlfifft,#.:'pfiYj.$:f-fif!$/ !d:t\£iE~ 'f:6:i1. 'f:Q;gT

THAMES PHARMACAL 0.025r. M O.lr. * ~ INJECTABLE; INJECTION

KENALOG-40 BP ER SQUIBB AND SONS 40MG/ML

TRIAMCINOLONE ACETONIDE SP CARTER-GLOGAU LABS 40MGIHL~

NUMBER 12 I AUGUST '81 - AUGUST '82

>~>

>~>

TRIAMCINOLONE ACETONIDE (PAGE 143)

AT

OINTMENT; TOPICAL KF.P.AC

NNC LABORATORIES ~~ T~rAMCINOlOHE ACETONIDE

AT CLAY-PARK LABS 0.02570" M O.lZU M O.S7o"

TRICHLORMETHIAZIDE (PAGE 144)

TABLET; ORAL TRICHLORMETHIAZIDE

BP PRENO FHARN LABS 4MG~

TRIFLUOPERAZINE HYDROCHLORTDE (PAGE 144)

CONCENTRATE; ORAL STELAZ:tNE

AA SK&F /#iki:i.Htl

TFP AA CORD LABORATORIES

TABLET; ORAL Sn:LAZltlE

AB SK&F AB

TR'!AZIHE AS CORD LABORATORIES AB

EQ lCMG BASE/ML

I::g lOHG BASE/MLll

EQ l~ B~S~ * Fo9 2M3 B~~E M EQ !;~G BASE * 1::9 lOW:; BM;;!'!:

Eg UlG BASElt M E9 2M3 BA!'Ell * Eq SNG BASE~ M EQ lO~~G S{~SEll

TRIHEXYPHENIDYL HYDROCHLORIDE (PAGE 145)

TABLET; ORAL TR7'Ht'XY~:-:EHInYL Met.

AA VANGARD LABS/NWN 2Mgn

TRIHEPRAZINE TARTRATE (PAGE 145)

SYRUP; ORAL ~~J:l

AA SK&F LABORATORIES TR!MEI!PA7IH! TARTRATE

Eq 2.5MG BASE/SMl

AA HATL PHARM MFG/BARRE 1::9 2.5M3 BASE/5MLll

TRIMETHOPRIH (PAGE 146)

TABLET; ORAL F~OLOr~!M

AS BURROUGHS WELLCOME lOn~G 200MG!:1:

TJ:1IM:rrH!:'r:'R!M AB BIOCRAFT LABS !~~f~it

Page 34: APPROVED PRESCRIPTION DRUG PRODUCTS

I" t ..

DRUG PRODUCT LIST / CUMULATIVE SUPPLEMENT ~~ER 12 / AUGUST '81 - .AUGUST '82 28

TRIPROLIDINE HYDROCHLORIDE (PAGE 1461

SYRUP; ORAL TRXPROLID:tHE HOL

AA PHARMS ASSOC/BEACH 1.25MG/5ML~

TRISULFAPYRIMIDINES (PAGE 1461

SUSPENSION; ORAL SULJ:ALOJ:D

I liM 7p)tf.'#.;¢~P.PIV.U-pjl IsddMS)SML/ AS ONEAL JONES&FELDMAN 500MG/5ML

TABLET; ORAL TRXPLE SULJ:A

I MY 7~fl~tf.#,,»<Jj.~pf.Jl.I IsddMGI AB PUREPACIKALIPHARM 500HG

TROPICAMIDE (PAGE 1471

SOLUTION/DROPS; OPHTHALMIC

I~J~~E~~~~¢pp.fijPP'j.t$1 I,d.: t>t.: 1:: f.t.1 MYDRJ:ACYL

>~> AT ALCON LABORATORIES o.~/. * ~ TROPiCAMiDE

>~> AT PRO PHARMA/STERI-MED O.5?'~ * ~

VERAPAMIL HYDROCHLORIDE (PAGE 1481

TABLET; ORAL ISOPTIN

KNOLL PHARMACEUTICAL 80MG~ * 120MG~ INJECTABLE; INJECTION

ISOPTIN KNOLL PHARMACEUTICAL 2.5MG/ML~

WARFARIN SODIUM (PAGE 1491

TABLET; ORAL ATHROMBIN

>-'ill-> I¢~I Ipyp.~~~:f~~~~~;l¢J{1 ~~~~~7' 'f.,dtl¢1 > DLT > > ADD > BX PURDUE FREDERICK >~>

COUMADIN

5MG * lOMG 25MG

> 0 L T > I¢'~I I ~tl~p: tfi¢,~~~pptlj I I ttl¢: 1:: t.: t>tl¢: 1:: t>tl¢: 1:: .1.: t>tl¢: 1:: f..dtl~1 >~> BX ENDO LABSIDUPONT 2MG * 2.5HG * 5MG * 7.5MG * 10MG

PANWARFIN > -'ill-> I~~I I fi~¢,p:t:t.· tJ.¢,p~fi:tp~j.~$1 I ttl¢.' 1:.' t.:t>~~.· 1:,' t>~S;,' 1:.' j.:t>~~.' 1:. 'f.,dtlrf,1 >~> BX ABBOTT LABORATORIES 2MG * 2.5MG * 5MG * 7.5MG * 10MG > ADD > WARFARIN SODIUM

BOLAR PHARMACEUTICAL 2MG~ * 2.5MG~ * 5MG~ * 7.5MG~ *

WATER FOR INJECTION (PAGE 1501

LIQUID; INJECTION STERnE WATE~ "!"H !'LA~TT.C cn:I1"AIN!':R

AP ABBOTT LABORATORIES 100% AP CUTTER LABORATORIES 100% AP TRAVENOL LABS l(lO;~!t

XENON, XE-133 (PAGE 150)

1M! AA

lW AA

GAS; INHALATION x!nmr; XE 133 JI3:t#I'lil{it¢. 'j.'j,frjpp.Et,f lio,:,:}.otlct.)!.MP!

MEDI-PHYSICS 10-20MCI/AMP MALLINCKRODT lO~!C:r/VIAL~ * 20MC:I/V:tALl:t

I Ii.E.o:.o j.fis;)rt: r~¢.Ltfip.I I "1C~\aVlJtA LI I ?.d~¢J.)9j.ftl

MED DIAG/NE NUCLEAR lCHCI/VJ:AL * 20MC:r:;VIAL

INJECTABLE; INJECTION XENON XE 133 Ip;t.#NP~jj.¢.·.t~Pfppt~,·If.,:.3.:';C.7¢j)firiPi

HEDl-PHYSICS 1.3-1.7CI/AMP

Page 35: APPROVED PRESCRIPTION DRUG PRODUCTS

ADDENDUM DESI PENDING LIST

29

CUMULATIVE SUPPLEMENT NUMBER 12 / AUGUST 'SI - AUGUST 'S2

CURRENT STATUS - PROBABLY EFFECTIVE

IpfiRfifPNI IM¢Ntjt'p~fiRMI I fi#j fiMjNPP~ttU. ·¢~tPRtp#tPNtl

IP7~2~~~~i~~~~'tU. ·f~m~~&~~~~~~~ 1$~~~~l~~~~:'~Pt~~~~~~;~~~~~~jJ~~Ntl Ij 7~B~Z~j~~. ·tx~~~~~l~~~~~~~~~$PNtI

CURRENT STATUS - INEFFECTIVE

ACTIFED-C EXPECTORANT BURROUGHS WELLCOME CODEINE PHOSPHATE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYUROCHLORIDE

I fi7~~~~~~~~~ .. ~ .. ~~~~~~~7~$· ·~ttt¢Pr1t1

I fi7~~i~~~ppJ~;fNj~RPP.· tfi~$;f;jtRtI

AMBENYL EXPECTORANT MARION LABORATORIES AMMONIUM CHLORIDE; BROMODIPHENHYDRAMINE HYDROCHLORIDE; CODEINE SULFATE; DIPHENHYDRAMINE HYDROCHLORIDE; MENTHOL; POTASSIUM GUAIACOLSULFONATE

/~7~~M~~~M.·f~i~~i~~1~a1~~~~~jPRfiM.tNt.·MpRP¢~tPR;tPt.f.·MtNj~ptl /$pp;fpr1.'¢;ffRfijt/

BLEPHAMIDE ALLERGAN PHARMS PHENYLEPHRINE HYDROCHLORIDE; PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM

/~~li~~1~~~~~~B~~~;tp/~~t~~G~i~~:j~~1~~~$;tpr1.·jR;t~;tf-;t.cfift}/ /p~tNit~pjfitPNt/

CLISTIN RA MCNEIL PHARM CARBINOXAMATE MALEATE

DIMETANE EXPECTORANT AH ROBINS BROMPHENIRAMINE MALEATE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; PHENYLPROPANOLAMINE HYDROCHLORIDE

CURRENT STATUS - INEFFECTIVE

DIMETANE EXPECTORANT-DC AH ROBINS BROMPHENIRAMINE MALEATE; CODEINE PHOSPHATE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; PHENYLPROPANOLAMINE HYDROCHLORIDE

FORHISTAL 'CIBA/CIBA-GEIGY DIMETHINDENE MALEATE

I t7~~~~~~1~~. ·~i~~~~~~g~~~~J~MZ~~J~;tN .. ~ .. $~tf fijU METAMINE PFIZER LABS/PFIZER

TROLNITRATE PHOSPHATE

NITRANITOL MERRELL-NATLIR-MERRL MANNITOL HEXANITRATE

NITRETAMIN ER SQUIBB AND SONS TROLNITRATE PHOSPHATE

NITRETAMIN-I0 ER SQUIBB AND SONS TROLNITRATE PHOSPHATE

I P~~~~~j~~M~?fpMPf~~]~~~f;t¢jt;t¢.· l.¢;tpi

OMNI-TUSS PE~~ALT PHARM CHLORPHENIRAMINE MA~EATE; CODEINE SULFATE; EPHEDRINE SULFATE; GUAIACOL CARBONATE; PHENYLTOLOXAMINE DIHYDROGEN SULFATE

PARAFON tlCNEIL PHARM ACETAMINOPHEN; CHLORZOXAZONE

PARAFON FORTE MCNEIL PHARM ACETAMINOPHEN; CHLORZOXAZONE

/ P7~~~~~~~~~;~~Z~~J~~~j~~~~~~~~:'i~{PR;t~l7P tR.Lt .. tfi~$) fitl .. ¢i fiNI

PENTESTAN-SO STANDEX LABS PENTAERYTHRITOL TETRANITRATE

PENTYRATE OJ&F/CHROMALLOY PENTAERYTHRITOL TETRANITRATE

~:;--

PHENERGAN EXPECTORANT WYETH LABS/AMHO CITRIC ACID; IPECAC; POTASSIUM GUAIACOLSULFONATE; PROMETHAZINE HYDROCHLORIDE; SODIUM CITRATE

PHENERGAN EXPECTORANT W/CODEINE WYETH LABS/AMBO CITRIC ACID; CODEINE PHOSPHATE; IPECAC FLUID EXTRACT; POTASSIUM GUAIACOLSULFONATE; PROMETHAZINE HYDROCHLORIDE; SODIUM CITRATE

Page 36: APPROVED PRESCRIPTION DRUG PRODUCTS

DESI PENDING LIST / CUMULATIVE SUPPLEMENT ~~ER 12 I AUGUST '81 - AUGUST '82 30

CURRENT STATUS - INEFFECTIVE

PHENERGAN EXPECTORANr W/ DEXTROMETHORPHAN WYETH LABS/AMHO CITRIC ACID; DEXTROMETHORPHAN HYDROBROMIDE; IPECAC FLUIDEXTRACT POTASSIUM GUAIACOLSULFONATE; PROMETHAZINE HYDROCHLORIDE; SODIUM CITRATE

PHENERGAN VC EXPECTORANT WYETH LABS/AMHO CITRIC ACID; IPECAC FLUIDEXTRACT; FHENYLEPHRINE HYDROCHLORIDE; POTASSIUM GUAIACOLSULFONATE; PROMETHAZINE HYDROCHLORIDE; SODIUM CITRATE

PHENERGAN VC EXPECTORANT WI CODEINE WYETH LABS/AMHO CITRIC ACID; CODEINE PHOSPHATE; IPECAC FLUIDEXTRACT; PHENYLEPHRINE HYDROCHLORIDE; POTASSIUM GUAIACOLSULFONATE; PROMETHAZINE HYDROCHLORIDE; SODIUM CITRATE

/ F'~~Z§%t\., p~~~i~;J~~~~a~~~~., PFPp;ipN,.{jt/ /j'~~M~i~j~~~;ijpf~~~q~~~J~#~~~1' ')-lP;3P/

TUSSIONEX PE~~ALT PHARM DIHYDROCODEINONE; PHENYLTOLOXAMINE DIHYDROGEN SULFATE

CURRENT STATUS - 'EXEMPT' (COURT ORDER)

/ f%~~~~~PHt~~~~~~~~~~~~~Z~~~~~::. 'P~.i. ':tFjPP.L;tP;ttlt. 'HYPRP¢H.LPF;ipt!

/ fjj;tftP.-=~. :~~~~¢:tRFfi~V Yfil~0RRPY~)-l~. '~t.L.L¢pt\t/ /~~~~B~tPHt¢F~~f~j~~p~)-lfB~1~~1B~.f. 'jFjpRP~;tP;tNt. 'H,vPFP¢H.LPF;ipt/

/ fi~~~~~~;~~~2~{~~1~~1. '~F~~B~l~~~~~~B~~~l~~~~~PFPtM.LPF;tp tJ / ~~g~~~~l~~~~~~J~B~~~~~~~~{~~?t\;iNt. 'tljp RPt.H.LPF;ip tJ .. tlttlftlp.LJ /

BAROPHEN NATL PHARM MFG/BARRE ATROPINE SULFATE; HYOSCYAMINE SULFATE; PHENOBARBITAL; SCOPOLAMINE HYDROBROMIDE

BAY-ASE BAY LABORATORIES ATROPINE SULFATE; HYOSCYAMINE SULFATE; PHENOBARBITAL; SCOPOLAMINE HYDROBROMIDE

BELLADONNA ALKALOIDS W/ PHENOBARBITAL LEMMON ATROPINE SULFATE; HYOSCYAMINE SULFATE; PHENOBARBITAL; SCOPOLAMINE HYDROBRONIDE

BElLASTAL ~~ARTON/US ETHICALS ATROPINE SULFATE; HYOSCYAMINE SULFATE; PHENOBARBITAL; SCOPOLAMINE HYDROBROMIDE

CURRENT STATUS - 'EXEMPT' (COURT ORDER)

/ ~.Ltptlf.tltp fJ / f.l(ER~f.N.· Pli;~Rt1M ~;Gl~12g1M~~: :~~8~BM~PRjP tJ.' pptpN;t~P.LPNt.· f¢tf Aft} /

BUTASAR BELLADONNA NATL PHARM MFGIBARRE BELLADONNA ALKALOIDS; BUTABARBITAL SODIUM

/ ¢f.~P ts:ppf / / pt~lilYA.L:f.' rHJpt1f / tfi.Ltt0r1. '0NPt¢j UNfftJ. 'tl.VPRP.cppfJ.s.ot1t. 'f..¢tf fft!

CHARDONNA-2 WILL!AM H RORER BELLADONNA EXTRACT; PHENOBARBITAL

/ ¢(t$jjN.' txrt¢fPpfNf / / tl¢I'lt.t.L.' rriAR/V / fitlMt~;t!JM.' ¢tl~PRtp (;.' ¢AR~Np#MjN.E. 'Mfi.LtMtJ / / ppf f$;3;t0ti.' ~0fi.;tf¢p~~0.LfPNr\ft}.' $PP ,to;-1.' ¢j.fplfU

/¢7z~~~1~~~~tif.j~~~~f~);~~f.Rti/

/ ¢~~lj~i?~¢j.p~:-B~~~~~~~~B~~~~:~gif Ap.fpfif (; / / ppf f.$~j0tl.' ~0fi.;tf¢p~$0.Lf ptlfiftJ.' $PP ;i0ti.' ¢;ifRlft/

/ ¢~~~~i~j~~~~~.L0ji~~1~~j1~B~~%~B;J~M~J.' tl.VPFP¢PRjj$ptlt/

/ ¢~'~~~~~~~ttlpf1~~/~~Z?~¢;ttl.' $0.L1 fi.ftl

/p;iMtNtlt. 'tXt-t¢fPRfiNf / / fit!. 'pMf.t~M / ¢RP)l.PMtNtpfMt-lt. ·tlfi.Ltfif(;.' ~0i{j.f tNt.s,tM! / pJ-lttl.Y ~t.Prl.Rj.N( 'ti.Y.DRPtM.LP,Rjp tJ / / ptlttV .LPRPP}tlPUtl,ttlt.' MjPRP¢tl.LPP,tPt!

/P,ttltff.Nt. 'txptt.fppfNf:~pt./ / Arl. '.RPti.INN / ~,RP)1F~tNtRfit\;itlt.' MfUfiftJ.' ¢~pt,tNt.' PMP.sp~fjt.;.' ;;0;-\;tt tr~t;3;iNJ / / pJltN:l .LtFMR;ttlt.' Ji),PRP.CM.Lppjp tJ / / PMtM .Lp~.oP fNP~AM;tNt.' )-ljpRPt)-l~PRjp t!

DIPYRIDAMOLE DANBURY PHARMACAL DIPYRIDAMOLE

DIPYRIDAMOLE LEDERLE LABS/AM CYAN DIPYRIDAMOLE

DIPYRIDAMOLE MYLAN PHARMS DIPYRIDAMOLE

DIPYRIDAMOLE WESTERN RES LABS DIPYRIDAMOLE

DIPYRIDAMOLE VANGARD LABS/M~M

DIPYRIDAMOLE

Page 37: APPROVED PRESCRIPTION DRUG PRODUCTS

DESI PENDING LIST / CUMULATIVE

CURRENT STATUS - 'EXEMPT' (COURT ORDER)

/P7B~~g~~p~t~1~1~~~~~~AttAjt/ /P7~~~~g~~~t. ,~~~~~~~~~~~~~~y

/P~~i~~~~~~~~~p~t~~~~~~~~~~~7PNA/ ELIXIR SUSANO HALSEY DRUG

ATROPINE SULFATE; HYOSCYAMINE SULFATE; PHENOBARBITAL; SCOPOLAMINE HYOROBROMIDE

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!F~~~~i~~j~Pt~~:'~~{~~J~?;~tf.~j/ HOMAPIN-5 PB MISSION PHARMACAL

HOMATROPINE METHYLBROMIDE; PHENOBARBITAL

HOMAPIN-I0 PB MISSION PHARMACAL HOMATROPINE METHYLBROMIDE; PHENOBARBITAL

ISOSORBIDE DINITRATE ASCOT HOSP PHARMS ISOSORBIDE DINITRATE

ISOSORBIDE DiNITRATE VANGARD LABS/NWM ISOSORBIDE DINITRATE

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METHANDROSTENOLONE BOLAR PHARMACEUTICAL METHANDROSTENOLONE

> ADD > METHANDROSTENOLONE PAR PHARMACEUTICAL > ADD > METHANDROSTENOLONE

NANDROLONE DECANOATE CARTER-GLOGAU LABS NANDROLONE DECANOATE

NANDROLONE PHENPROPIONATE CARTER-GLOGAU LABS NANDROLONE PHENPROPIONATE

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ENT NUMBER 12 / AUGUST '81 - AUGUST '82

CURRENT STATUS -''-'''EXEMPT' (COURT ORDER)

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/tl7~~31MJ~~§~~ PBP~~~~~~7f~¢. ·A~P.' $PN~/ NITRO-OUR KEY PHARMACEUTICALS

NITROGLYCERIN

NITRODISC SEARLE PHARMS NITROGLYCERIN

NITROGLYCERIN ASCOT HOSP PHARMS NITROGLYCERIN

>--AQ!L> NITROGLYCERIN VITARINE/WEST CHEM >~> NITROGLYCERIN

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PENTAERYTHRITOL TETRANITRATE VANGARD LABS/Mk~

PENTAERYTHRITOL TETRANITRATE

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Page 38: APPROVED PRESCRIPTION DRUG PRODUCTS

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DESI PENDING LIST / CUMULATIVE SUPPLEMENT NUMBER 12 / AUGUST '81 - AUGUST '82 32

CURRENT STATUS - 'EXEMPT' (COURT ORDER)

PERITRATE SR PARKE-DAVISIW-lIPR PENTAERYTHRITOL TETRANITRATE

PERSANTINE-50 BOEHRINGER INGELHEIM DIPYRIDAMOLE

PERSANTINE-75 BOEHRINGER INGELHEIM DIPYRIDAMOLE

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NITROGLYCERIN

SUSANO HALSEY DRUG ATROPINE SULFATE; HYOSCYAMINE SULFATE; PHENOBARBITAL; SCOPOLAMINE HYDROBROMIDE

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/j~~~~~~~~~~~~~~~~g~l~~~~~~1~~~~l~~!~~i~~~~~i~~~~~,1;Rp~~.EI TRANSDERM-NITRO~5 AlZA

NITROGLYCERIN-~

TRANSDERM-NITRO 5 AlZA NITROGLYCERIN

TRANSDERM-NITRO 10 AlZA YCERIN

CURRENT STATUS - 'EXEMPT' (COURT ORDER)

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CURRENT STATUS - EFFECTIVE/NEW SAFETY ISSUE

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