exhibit 27 - downloads.regulations.gov€¦ · drugs@fda: fda approved drug products page 2 of 2...
Post on 12-Nov-2020
5 Views
Preview:
TRANSCRIPT
27
Exhibit 27
Drugs@FDA: FDA Approved Drug Products Page 1 of 2
FDA Home 3 Drua Databases4 DrugsPFDA5
Drugs®F041 FDA Approved Drug Products
FAQ6 I Instructions 7 I Glossary 8 I Contact Us 9
gEmail Link
Start Over
Back to Search Results
Drug Details
Drug Name(s)
FDA Application No.
Active Ingredient(s)
Company
Original Approval or Tentative Approval Date
• Therapeutic Equivalents
• Approval History, Letters, Reviews, and Related Documents
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)
(ANDA) 203263
DOXORUBICIN HYDROCHLORIDE
SUN PHARMA GLOBAL
February 4, 2013
• Label Information
Products on Application (ANDA) #203263 Click on a column header to re-sort the table:
Drug Name Active Ingredients Strength Dosage Form/Route Marketing RLDTE Status Code
DOXORUBICIN HYDROCHLORIDE
DOXORUBICIN HYDROCHLORIDE
20MG/10ML (2MG/ML)
INJECTABLE, LIPOSOMAL;INJECTION
Prescription Yes AB
(LIPOSOMAL) DOXORUBICIN HYDROCHLORIDE
DOXORUBICIN HYDROCHLORIDE
50MG/25ML (2MG/ML)
INJECTABLE, LIPOSOMAL;INJECTION
Prescription Yes AB
(LIPOSOMAL)
Back to Top I Back to Previous Page I Back to Drugs@FDA Home
Disclaimer 30 FDA/Center for Drug Evaluation and Research Office of Communications Division of Online Communications Update Frequency: Daily
Links on this page:
1. http://www. addthis.com/bookmark.php?u508=true&v=152&username=fdamain
2. http://www. addthis.com/bookmark.php
3. http://www. fda.gov/default.htm
4. http://www .fda.gov/Drugs/InformationOnDrugs/default.htm
5. http://www .accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
6. http://www .fda.gov/Drugs/InformationOnDrugs/ucm075234.htm
7. http://www .fda.gov/Drugs/InformationOnDrugs/UCM079874
8. http://www .fda.gov/Drugs/InformationOnDrugs/ucm079436.htm
9. http://www .accessdata.fda.gov/scripts/email/cder/commentdrugcat.cfm
10. http://www .fda.gov/AboutFDA/AboutThisWebsite/WebsitePolicies/default.htm#web
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Accessibility Contact FDA Careers FDA Basics FOIA No Fear Act Site Map Transparency Website Policies
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugD.. . 2/4/2014
Drugs@FDA: FDA Approved Drug Products Page 2 of 2
U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. 1-888-INFO-FDA (1-888-463-6332) Email FDA
Li C2 El For Government For Press
Combination Products Advisory Committees Science & Research Regulatory Information Safety Emergency Preparedness International Programs News & Events Training and Continuing Education Inspections/Compliance State & Local Officials Consumers Industry Health Professionals FDA Archive
4 U.S. Department of Health & Human Services
Links on this page:
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugD.. . 2/4/2014
28
Exhibit 28
Prescription and Over-the-Counter Drug Product List 33rd Edition
Cumulative Supplement Number 6: June 2013
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST
ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE
CAPSULE; ORAL
ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE
>D> AA WRASER PHARMS LLC 356.4MG;30MG;16MG A040688 001 Apr 03, 2007 Jun DISC >A> 356.4MG;30MG;16MG
TABLET; ORAL
A040688 001 Apr 03, 2007 Jun DISC
ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE
>D> AA BOCA PHARMA 712.8MG;60MG;32MG A040701 001 Apr 03, 2007 Jun DISC >A> 712.8MG;60MG;32MG
ACETAMINOPHEN; CODEINE PHOSPHATE
A040701 001 Apr 03, 2007 Jun DISC
TABLET; ORAL
ACETAMINOPHEN AND CODEINE PHOSPHATE
>D> AA MIKART 300MG;30MG A089238 001 Feb 25, 1986 Jun DISC >A> 300MG;30MG
ACETAMINOPHEN; HYDROCODONE BITARTRATE
A089238 001 Feb 25, 1986 Jun DISC
CAPSULE; ORAL
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
>D> AA MIKART 500MG;5MG A089008 001 Feb 21, 1986 Jun DISC >A> 500MG;5MG
TABLET; ORAL
A089008 001 Feb 21, 1986 Jun DISC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
>A> AA CARACO 650MG;7.5MG A090380 001 Dec 23, 2008 Jun CAHN >A> AA 650MG;10MG A090380 002 Dec 23, 2008 Jun CAHN >A> AA 660MG;10MG A090380 003 Dec 23, 2008 Jun CAHN >A> AA 750MG;7.5MG A090380 004 Dec 23, 2008 Jun CAHN >D> AA SUN PHARM INDS INC 650MG;7.5MG A090380 001 Dec 23, 2008 Jun CAHN >D> AA 650MG;10MG A090380 002 Dec 23, 2008 Jun CAHN >D> AA 660MG;10MG A090380 003 Dec 23, 2008 Jun CAHN >D> AA 750MG;7.5MG
ACYCLOVIR
A090380 004 Dec 23, 2008 Jun CAHN
SUSPENSION; ORAL
ZOVIRAX
>A> AB + DELCOR ASSET 200MG/5ML N019909 001 Dec 22, 1989 Jun CAHN >D> AB + GLAXOSMITHKLINE 200MG/5ML
ALPRAZOLAM
N019909 001 Dec 22, 1989 Jun CAHN
TABLET, EXTENDED RELEASE; ORAL
ALPRAZOLAM
>D> AB TEVA PHARMS 0.5MG A077979 001 Feb 28, 2007 Jun DISC >0> AB 1MG A077979 002 Feb 28, 2007 Jun DISC >D> AB 2MG A077979 003 Feb 28, 2007 Jun DISC >D> AB 3MG A077979 004 Feb 28, 2007 Jun DISC >A> @ TEVA PHARMS USA 0.5MG A077979 001 Feb 28, 2007 Jun DISC >A> 1MG A077979 002 Feb 28, 2007 Jun DISC >A> 2MG A077979 003 Feb 28, 2007 Jun DISC >A> 3MG
AMIKACIN SULFATE
A077979 004 Feb 28, 2007 Jun DISC
INJECTABLE; INJECTION
AMIKACIN SULFATE
>D> @ TEVA PARENTERAL EQ 50MG BASE/ML A064045 001 Sep 28, 1993 Jun CAHN
PaRelofi9
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST
>D>
>A> >A>
AP
AP
INJECTABLE; INJECTION
AMIKACIN SULFATE
TEVA PARENTERAL @ TEVA PHARMS USA
EQ 250MG BASE/ML EQ 50MG BASE/ML
EQ 250MG BASE/ML
A064045
A064045 A064045
002 001 002
Sep Sep Sep
28, 28,
28,
1993 1993
1993
Jun
Jun Jun
CAHN
CAHN CAHN
AMINOPHYLLINE
INJECTABLE; INJECTION
AMINOPHYLLINE
>D> AP INTL MEDICATION 251,4G/mL A087209 001 Feb 01, 1982 Jun DISC >A> 9 25mG/141, A087209 001 Feb 01, 1982 Jun DISC >D> AP PHARMA SERVE NY 25MG/ML A087392 001 Dec 15, 1983 Jun DISC >A>
>D>
9
AMLEXANOX
25MG/ML A087392 001 Dec 15, 1983 Jun DISC
>D> PASTE; DENTAL
>D> APHTHASOL
>D> + ULURU 5% NO20511 001 Dec 17, 1996 Jun DISC >A> 9
AMMONIA N-13
5% NO20511 001 Dec 17, 1996 Jun DISC
INJECTABLE; INTRAVENOUS
AMMONIA N 13
>A> AP UCLA BIOMEDICAL 30mci - 300mci/8mL (3.75 -
37.5MCl/ML) A203812 001 Jun 27, 2013 Jun NEWA
AMOXICILLIN
TABLET; ORAL
AMOXICILLIN
>D> AB DAVA PHARMS INC 875MG A065344 001 Jan 15, 2009 Jun DISC >A> 9
AMPICILLIN SODIUM
875MG A065344 001 Jan 15, 2009 Jun DISC
INJECTABLE; INJECTION
AMPICILLIN SODIUM
>D> AP ANTIBIOTICE EQ 250MG BAsE/vIAL A090354 001 Dec 28, 2009 Jun DISC >A> 9 EQ 250MG BAsE/vIAL A090354 001 Dec 28, 2009 Jun DISC >D> AP EQ 500MG BASE/VIAL A090354 002 Dec 28, 2009 Jun DISC >A> 9 EQ 500MG BASE/VIAL A090354 002 Dec 28, 2009 Jun DISC >D> AP EQ 1GM BASE/VIAL A090354 003 Dec 28, 2009 Jun DISC >A> 9 EQ 1GM BASE/VIAL A090354 003 Dec 28, 2009 Jun DISC >D> AP EQ 2GM BASE/VIAL A090354 004 Dec 28, 2009 Jun DISC >A> 9
AZELAIC ACID
EQ 2GM BASE/VIAL A090354 004 Dec 28, 2009 Jun DISC
GEL; TOPICAL
FINACEA
>A> + BAYER HLTHCARE 15% NO21470 001 Dec 24, 2002 Jun CAHN >D> + BHP DERMATOLOGY
BACITRACIN
15% NO21470 001 Dec 24, 2002 Jun CAHN
OINTMENT; OPHTHALMIC
BACITRACIN
>D> + FERA PHARMS 500 uNiTs/Gm A061212 001 Jun CAHN >A> + PERRIGO CO TENNESSEE 500 uNITs/Gm A061212 001 Jun CAHN
Paee 2 of 19
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
>D> AT
>A> AT
OINTMENT; OPHTHALMIC
NEOMYCIN AND POLYMYXIN
FERA PHARMS
PERRIGO CO TENNESSEE
B SULFATES AND BACITRACIN ZINC
400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM
400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM
A060764 002
A060764 002
Jun CAHN
Jun CAHN
BACITRACIN ZINC; POLYMYXIN B SULFATE
OINTMENT; OPHTHALMIC
BACITRACIN ZINC AND POLYMYXIN B SULFATE
>D> AT
FERA PHARMS 500 UNITS/GM;10,000 UNITS/GM A065022 001 Feb 27, 2002 Jun CAHN >A> AT
PERRIGO CO TENNESSEE 500 UNITS/GM;10,000 UNITS/GM A065022 001 Feb 27, 2002 Jun CAHN
>D>
>A>
BACITRACIN; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Jun
Jun
CAHN
CAHN
OINTMENT; OPHTHALMIC
BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE
+ FERA PHARMS 400 UNITS/GM;1%;EQ 3.5MG A062166 002 BASE/GM;10,000 UNITS/GM
PERRIGO CO TENNESSEE 400 UNITS/GM;1%;EQ 3.5MG A062166 002 BASE/GM;10,000 UNITS/GM
BENZOYL PEROXIDE; ERYTHROMYCIN
GEL; TOPICAL
BENZAMYCIN PAK
>D> + VALEANT INTL 5%;3% N050769 001 Nov 27, 2000 Jun CAHN >A> + VALEANT LUXEMBOURG 5%;3%
BETHANECHOL CHLORIDE
N050769 001 Nov 27, 2000 Jun CAHN
TABLET; ORAL
BETHANECHOL CHLORIDE
>A> AA CARACO 5MG A040897 001 Apr 22, 2009 Jun CAHN >A> AA 10MG A040897 002 Apr 22, 2009 Jun CAHN >A> AA 25MG A040897 003 Apr 22, 2009 Jun CAHN >A> AA 50MG A040897 004 Apr 22, 2009 Jun CAHN >D> AA LANNETT 5MG A040703 001 Mar 27, 2008 Jun DISC >0> AA 50MG A040677 001 Mar 27, 2008 Jun DISC >A> @ LANNETT HOLDINGS INC 5MG A040703 001 Mar 27, 2008 Jun DISC >A> 50MG A040677 001 Mar 27, 2008 Jun DISC >D> AA SUN PHARM INDS INC 5MG A040897 001 Apr 22, 2009 Jun CAHN >D> AA 10MG A040897 002 Apr 22, 2009 Jun CAHN >D> AA 25MG A040897 003 Apr 22, 2009 Jun CAHN >D> AA 50MG
BEXAROTENE
A040897 004 Apr 22, 2009 Jun CAHN
CAPSULE; ORAL
TARGRETIN
>D> + EISAI INC 75MG NO21055 001 Dec 29, 1999 Jun CAHN >A> + VALEANT LUXEMBOURG 75MG
GEL; TOPICAL
NO21055 001 Dec 29, 1999 Jun CAHN
TARGRETIN
>A> + VALEANT LUXEMBOURG 1% NO21056 001 Jun 28, 2000 Jun CAHN
>D> + VALEANT PHARMS INC 1%
BUPIVACAINE HYDROCHLORIDE
NO21056 001 Jun 28, 2000 Jun CAHN
INJECTABLE; INJECTION
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE
>D> AP INTL MEDICATED 0.25% A076012 001 Jan 09, 2002 Jun DISC >A> 0.25% A076012 001 Jan 09, 2002 Jun DISC >D> AP 0.5% A076012 002 Jan 09, 2002 Jur
Page 3 of 19
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT Lwr INJECTABLE; INJECTION
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE
>A> @ INTL MEDICATED 0.5% A076012 002 Jan 09, 2002 Jun DISC >D> AP 0.75% A076012 003 Jan 09, 2002 Jun DISC >A> 9
BUTORPHANOL TARTRATE
0.75% A076012 003 Jan 09, 2002 Jun DISC
INJECTABLE; INJECTION
>D> STADOL
>D> AP + APOTHECON 2MG/ML N017857 004 Jun DISC >A> @ 2MG/ML N017857 004 Jun DISC >D> STADOL PRESERVATIVE FREE
>D> AP + APOTHECON 1MG/ML N017857 001 Jun DISC >A> @ 1MG/ML N017857 001 Jun DISC >D> AP + 2MG/ML N017857 002 Jun DISC >A> @ 2MG/ML N017857 002 Jun DISC
>A>
>D>
CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
NO20577 001
NO20577 001
Sep
Sep
27,
27,
1996
1996
Jun
Jun
CAHN
CAHN
INJECTABLE; INTRATHECAL
ELLIOTTS B SOLUTION
+ LUKARE MEDICAL LLC
+ QOL MEDCL
0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3M G/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML 0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3M G/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML
CAPTOPRIL
TABLET; ORAL
CAPTOPRIL
>D> AB PRINSTON INC 12.5MG A074477 001 Feb 13, 1996 Jun DISC >A> @ 12.5MG A074477 001 Feb 13, 1996 Jun DISC >D> AB 25MG A074477 002 Feb 13, 1996 Jun DISC >A> @ 25MG A074477 002 Feb 13, 1996 Jun DISC >D> AB 50MG A074477 003 Feb 13, 1996 Jun DISC >A> @ 50MG A074477 003 Feb 13, 1996 Jun DISC >D> AB 100MG A074477 004 Feb 13, 1996 Jun DISC >A> @ 100MG A074477 004 Feb 13, 1996 Jun DISC >D> AB TEVA 12.5MG A074483 001 Feb 13, 1996 Jun DISC >A> @ 12.5MG A074483 001 Feb 13, 1996 Jun DISC >D> AB 25MG A074483 002 Feb 13, 1996 Jun DISC >A> @ 25MG A074483 002 Feb 13, 1996 Jun DISC >D> AB 50MG A074483 003 Feb 13, 1996 Jun DISC >A> @ 50MG A074483 003 Feb 13, 1996 Jun DISC >D> AB 100MG A074483 004 Feb 13, 1996 Jun DISC >A> @
CARBAMAZEPINE
100MG A074483 004 Feb 13, 1996 Jun DISC
CAPSULE, EXTENDED RELEASE; ORAL
CARBAMAZEPINE
>A> AB TARO 100MG A201106 001 Jun 21, 2013 Jun NEWA >A> AB 200MG A201106 002 Jun 21, 2013 Jun NEWA >A> AB
CARISOPRODOL
300MG A201106 003 Jun 21, 2013 Jun NEWA
TABLET; ORAL
CARISOPRODOL
>D> AA PROSAM LABS 350MG A040188 001 Mar 07, 1997 Jun DISC >A> 9 350MG A040188 001 Mar 07, 1997 Jur
Paae 4 of 19
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST
CEFOTAXIME SODIUM
INJECTABLE; INJECTION
CEFOTAXIME SODIUM
>D> AP AUROBINDO PHARMA EQ 10GM BASE/VIAL A065516 001 Nov 06, 2009 Jun DISC >A> 9 AUROBINDO PHARMA LTD
CEFTAZIDIME
EQ 10GM BASE/VIAL A065516 001 Nov 06, 2009 Jun DISC
INJECTABLE; INJECTION
CEFTAZIDIME
>D> AP AUROBINDO PHARMA 500MG/VIAL A065481 001 May 28, 2010 Jun DISC >D> AP 1GM/VIAL A065481 002 May 28, 2010 Jun DISC >D> AP 2GM/VIAL A065481 003 May 28, 2010 Jun DISC >D> AP 6GM/VIAL A065482 001 May 28, 2010 Jun DISC >A> 9 AUROBINDO PHARMA LTD 500MG/VIAL A065481 001 May 28, 2010 Jun DISC >A> 9 1GM/VIAL A065481 002 May 28, 2010 Jun DISC >A> 8 2GM/VIAL A065481 003 May 28, 2010 Jun DISC >A> 8
CEFUROXIME SODIUM
6GM/VIAL A065482 001 May 28, 2010 Jun DISC
INJECTABLE; INJECTION
>D> ZINACEF IN PLASTIC CONTAINER
>D> + COVIS PHARMA EQ 15MG BASE/ML N050643 001 Apr 28, 1989 Jun DISC >A> 8 COVIS PHARMA SARL
CETIRIZINE HYDROCHLORIDE
EQ 15MG BASE/ML N050643 001 Apr 28, 1989 Jun DISC
SYRUP; ORAL
CETIRIZINE HYDROCHLORIDE
>A> AA CARACO 5MG/5ML A090191 001 Nov 12, 2009 Jun CAHN >D> AA SUN PHARM INDS INC
CETRORELIX
5MG/5ML A090191 001 Nov 12, 2009 Jun CAHN
INJECTABLE; INJECTION
CETROTIDE
>D> + EMD SERONO EQ 3mG BASE/ML NO21197 002 Aug 11, 2000 Jun DISC >A> 9 EMD SERONO INC
CEVIMELINE HYDROCHLORIDE
EQ 3MG BASE/ML NO21197 002 Aug 11, 2000 Jun DISC
CAPSULE; ORAL
CEVIMELINE HYDROCHLORIDE
>A> AB ROXANE
CHLOROTHIAZIDE SODIUM
30MG A091591 001 Jul 08, 2013 Jun NEWA
INJECTABLE; INJECTION
CHLOROTHIAZIDE SODIUM
>A> AP LUITPOLD EQ 500MG BASE/VIAL A202561 001 Apr 22, 2013 Jun CAHN >D> AP PHARMAFORCE
CIMETIDINE
EQ 500MG BASE/VIAL A202561 001 Apr 22, 2013 Jun CAHN
TABLET; ORAL
CIMETIDINE
>D> AB WATSON LABS 800MG A074316 001 Feb 28, 1996 Jun DISC >A> 9 WATSON LABS INC 800MG
CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE
A074316 001 Feb 28, 1996 Jun DISC
TABLET, EXTENDED RELEASE; ORAL
CIPROFLOXACIN EXTENDED RELEASE
>D> AB DR REDDYS LABS LTD 212.6MG;EQ 287.5MG BASE A077701 002 Oct 31, 2007 Jun DISC >A> 9 212.6MG;EQ 287.5MG BASE A077701 002 Oct 31, 2007 Jun DISC
Pane 5 of 19
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST
CITALOPRAM HYDROBROMIDE
TABLET; ORAL
CITALOPRAM HYDROBROMIDE
>D> AB NATCO PHARMA LTD EQ 20MG BASE A077141 002 Apr 10, 2008 Jun DISC >A> EQ 20MG BASE A077141 002 Apr 10, 2008 Jun DISC >D> AB EQ 40MG BASE A077141 001 Apr 10, 2008 Jun DISC >A> EQ 40MG BASE
CLOBETASOL PROPIONATE
A077141 001 Apr 10, 2008 Jun DISC
AEROSOL, FOAM; TOPICAL
OLUX E
>A> AB2 + DELCOR ASSET 0.05% NO22013 001 Jan 12, 2007 Jun CAHN >D> AB2 + STIEFEL LABS INC 0.05%
CREAM; TOPICAL
NO22013 001 Jan 12, 2007 Jun CAHN
CLOBETASOL PROPIONATE
>D> AB1 TEVA PHARMS 0.05% A074087 001 Feb 16, 1994 Jun DISC >A> @ TEVA PHARMS USA 0.05%
CYTARABINE
A074087 001 Feb 16, 1994 Jun DISC
INJECTABLE; INJECTION
CYTOSAR-U
>D> AP TEVA PARENTERAL 100MG/VIAL A075206 001 Dec 30, 1998 Jun CAHN >D> AP 500MG/VIAL A075206 002 Dec 30, 1998 Jun CAHN >D> AP 1GM/VIAL A075206 004 Dec 30, 1998 Jun CAHN >D> AP 2GM/VIAL A075206 003 Dec 30, 1998 Jun CAHN >A> AP TEVA PHARMS USA 100MG/VIAL A075206 001 Dec 30, 1998 Jun CAHN >A> AP 500MG/VIAL A075206 002 Dec 30, 1998 Jun CAHN >A> AP 1GM/VIAL A075206 004 Dec 30, 1998 Jun CAHN >A> AP 2GM/VIAL
DALTEPARIN SODIUM
A075206 003 Dec 30, 1998 Jun CAHN
INJECTABLE; SUBCUTANEOUS
FRAGMIN
>D> EISAI INC 10,000IU/0.4ML (25,000IU/ML) NO20287 002 May 01, 2007 Jun DISC >A> 10,000IU/0.4ML (25,000IU/ML) NO20287 002 May 01, 2007 Jun DISC >D> 95,000IU/9.5ML (10,000IU/ML) NO20287 007 Apr 04, 2002 Jun DISC >A> 95,000IU/9.5ML (10,000IU/ML)
DESONIDE
NO20287 007 Apr 04, 2002 Jun DISC
GEL; TOPICAL
DESONATE
>A> + BAYER HLTHCARE 0.05% NO21844 001 Oct 20, 2006 Jun CAHN >D> + BHP DERMATOLOGY 0.05%
DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
NO21844 001 Oct 20, 2006 Jun CAHN
OINTMENT; OPHTHALMIC
NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE
>0> AT FERA PHARMS 0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM
A062938 001 Jul 31, 1989 Jun CAHN
>A> AT PERRIGO CO TENNESSEE 0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM
A062938 001 Jul 31, 1989 Jun CAHN
DIAZEPAM
INJECTABLE; INJECTION
DIAZEPAM
>D> AP WATSON LABS 5MG/ML A070296 001 Feb 12, 1986 Jun DISC
>A> 5MG/ML A070296 001 Feb 12, 1986 Jun DISC
Paae 6 of 19
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST
>D>
>A>
DIFLORASONE DIACETATE
0.05%
0.05%
NO20205
NO20205
001
001
Nov 20,
Nov 20,
1992
1992
Jun
Jun
CAHN
CAHN
CREAM; TOPICAL
PSORCON
@ TARO @ TARO PHARMS NORTH
DIGOXIN
TABLET; ORAL
DIGOXIN
>D> AB CARACO 0.125MG A076363 001 Jan 31, 2003 Jun DISC >A> @ 0.125MG A076363 001 Jan 31, 2003 Jun DISC >D> AB 0.25MG A076363 002 Jan 31, 2003 Jun DISC >A> @
DIPYRIDAMOLE
0.25MG A076363 002 Jan 31, 2003 Jun DISC
TABLET; ORAL
DIPYRIDAMOLE
>D> AB PROSAM LABS 25MG A040542 001 Apr 21, 2006 Jun DISC >A> @ 25MG A040542 001 Apr 21, 2006 Jun DISC >D> AB 50MG A040542 002 Apr 21, 2006 Jun DISC >A> @ 50MG A040542 002 Apr 21, 2006 Jun DISC >D> AB 75MG A040542 003 Apr 21, 2006 Jun DISC >A> @
DONEPEZIL HYDROCHLORIDE
75MG A040542 003 Apr 21, 2006 Jun DISC
TABLET; ORAL
DONEPEZIL HYDROCHLORIDE
>A> AB ALVOGEN PINE BROOK 5MG A202114 001 Jul 05, 2013 Jun NEWA >A> AB
DOXEPIN HYDROCHLORIDE
10MG A202114 002 Jul 05, 2013 Jun NEWA
CAPSULE; ORAL
DOXEPIN HYDROCHLORIDE
>D> AB + MYLAN PHARMS INC EQ 10MG BASE A070791 002 May 13, 1986 Jun CRLD >A> AB EQ 10MG BASE A070791 002 May 13, 1986 Jun CRLD >D> AB EQ 25MG BASE A070791 003 May 13, 1986 Jun CRLD >A> AB +
DOXORUBICIN HYDROCHLORIDE
EQ 25MG BASE A070791 003 May 13, 1986 Jun CRLD
INJECTABLE; INJECTION
DOXORUBICIN HYDROCHLORIDE
>D> AP TEVA PARENTERAL 2MG/ML A064140 001 Jul 28, 1995 Jun CAHN >D> AP 200MG/100ML A064140 002 Jul 28, 1995 Jun CAHN >A> AP TEVA PHARMS USA 2MG/ML A064140 001 Jul 28, 1995 Jun CAHN >A> AP 200MG/100ML A064140 002 Jul 28, 1995 Jun CAHN
INJECTABLE, LIPOSOMAL; INJECTION
DOXIL (LIPOSOMAL)
>D> AB + JANSSEN RES AND DEV 20MG/10ML (2MG/ML) N050718 001 Nov 17, 1995 Jun CRLD >A> AB 20MG/10ML (2MG/ML) N050718 001 Nov 17, 1995 Jun CRLD >0> AB + 50MG/25ML (2MG/ML) N050718 002 Jun 13, 2000 Jun CRLD >A> AB 50MG/25ML (2MG/ML) N050718 002 Jun 13, 2000 Jun CRLD
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)
>D> AB SUN PHARMA GLOBAL 20MG/10ML (2MG/ML) A203263 001 Feb 04, 2013 Jun CRLD >A> AB + 20MG/10ML (2MG/ML) A203263 001 Feb 04, 2013 Jun CRLD >D> AB 50MG/25ML (2MG/ML) A203263 002 Feb 04, 2013 Jun CRLD >A> AB + 50MG/25ML (2MG/ML) A203263 002 Feb 04, 2013 Jun CRLD
Paae 7 of 19
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST
ERTAPENEM SODIUM
IV (INFUSION) INJECTABLE; INTRAMUSCULAR,
INVANZ >D> + MERCK EQ 1GM BASE/VIAL 14021337 001 Nov 21, 2001 Jun CAHN >A> + MERCK SHARP DOHME
ERYTHROMYCIN
EQ 1GM BASE/VIAL 14021337 001 Nov 21, 2001 Jun CAHN
OINTMENT; OPHTHALMIC ERYTHROMYCIN
>D> AT + FERA PHARMS 0.5% A062447 001 Sep 26, 1983 Jun CAHN >A> AT + PERRIGO CO TENNESSEE
ESTRADIOL VALERATE
0.5% A062447 001 Sep 26, 1983 Jun CAHN
INJECTABLE; INJECTION
ESTRADIOL VALERATE >D> AO WATSON LABS 20MG/ML A083547 001 Jun DISC >D> AO 40MG/ML A083714 001 Jun DISC >A> 0 40MG/ML A083714 001 Jun DISC >A> 8 WATSON LABS INC 20MG/ML A083547 001 Jun DISC
>D> ESTRONE
>D> INJECTABLE; INJECTION >D> ESTRONE >D> + WATSON LABS 5MG/ML A085239 001 Jun DISC >A> @ 5MG/ML A085239 001 Jun DISC
FINASTERIDE
TABLET; ORAL FINASTERIDE
>A> AB HETERO LABS LTD III 1MG A090060 001 Jul 01, 2013 Jun NEWA >A> AB SUN PHARMA GLOBAL
FLUDEOXYGLUCOSE F-18
1MG A090508 001 Jul 01, 2013 Jun NEWA
INJECTABLE; INTRAVENOUS FLUDEOXYGLUCOSE F18
>D> HOUSTON CYCLOTRON 20-500mCi/ML A203665 001 Feb 14, 2013 Jun CRLD >A> + 20-500mCi/ML A203665 001 Feb 14, 2013 Jun CRLD >A> + UCLA BIOMEDICAL
FLUVOXAMINE MALEATE
4-40mCi/ML A203811 001 Jun 27, 2013 Jun NEWA
TABLET; ORAL FLUVOXAMINE MALEATE
>D> AB CARACO 25MG A075900 001 Feb 23, 2006 Jun DISC >A> @ 25MG A075900 001 Feb 23, 2006 Jun DISC >D> AB 50MG A075900 002 Feb 23, 2006 Jun DISC >A> 0 50MG A075900 002 Feb 23, 2006 Jun DISC >D> AB 100MG A075900 003 Feb 23, 2006 Jun DISC >A> 8
GABAPENTIN
100MG A075900 003 Feb 23, 2006 Jun DISC
SOLUTION; ORAL
GABAPENTIN >A> AA TARO
GEMFIBROZIL
250MG/5ML A076672 001 Jul 03, 2013 Jun NEWA
TABLET; ORAL GEMFIBROZIL
>A> AB CARACO 600MG A079239 001 Dec 29, 2008 Jun CAHN
Paee 8 of 19
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST TABLET; ORAL
GEMFIBROZIL
>0> AB SUN PHARM INDS INC
GENTAMICIN SULFATE
600MG A079239 001 Dec 29, 2008 Jun CAHN
OINTMENT; OPHTHALMIC
GENTAMICIN SULFATE
>D> AT FERA PHARMS EQ 0.3% BASE A065024 001 Jul 30, 2004 Jun CAHN >A> AT PERRIGO CO TENNESSEE
SOLUTION/DROPS; OPHTHALMIC
EQ 0.3% BASE A065024 001 Jul 30, 2004 Jun CAHN
GENTAMICIN SULFATE
>D> AT FERA PHARMS EQ 0.3% BASE A065121 001 Jan 30, 2004 Jun CAHN >A> AT PERRIGO CO TENNESSEE
GUANFACINE HYDROCHLORIDE
EQ 0.3% BASE A065121 001 Jan 30, 2004 Jun CAHN
TABLET; ORAL
GUANFACINE HYDROCHLORIDE
>D> AB EPIC PHARMA EQ 1MG BASE A074673 001 Feb 28, 1997 Jun DISC >D> AB EQ 2MG BASE A074673 002 Feb 28, 1997 Jun DISC >A> @ EPIC PHARMA LLC EQ 1MG BASE A074673 001 Feb 28, 1997 Jun DISC >A>
HALOBETASOL PROPIONATE
EQ 2MG BASE A074673 002 Feb 28, 1997 Jun DISC
OINTMENT; TOPICAL
HALOBETASOL PROPIONATE
>A> @ G AND W LABS INC 0.05% A077109 001 Jun 14, 2005 Jun CAHN >D> @ VENUS PHARMS
HALOPERIDOL DECANOATE
0.05% A077109 001 Jun 14, 2005 Jun CAHN
INJECTABLE; INJECTION
HALOPERIDOL DECANOATE
>D> AO TEVA PARENTERAL EQ 50MG BASE/ML A075393 001 May 11, 1999 Jun CAHN >D> AO EQ 100MG BASE/ML A075393 002 May 11, 1999 Jun CAHN >A> AO TEVA PHARMS USA EQ 50MG BASE/ML A075393 001 May 11, 1999 Jun CAHN >A> AO
HALOPERIDOL LACTATE
EQ 100MG BASE/ML A075393 002 May 11, 1999 Jun CAHN
INJECTABLE; INJECTION
HALOPERIDOL
>D> AP TEVA PARENTERAL EQ 5MG BASE/ML A076035 001 Aug 29, 2001 Jun CAHN
>A> AP TEVA PHARMS USA
HYDRALAZINE HYDROCHLORIDE
EQ 5MG BAsE/NIL A076035 001 Aug 29, 2001 Jun CAHN
TABLET; ORAL
HYDRALAZINE HYDROCHLORIDE
>D> AA ZYDUS PHARMS USA 10MG A040858 001 Feb 26, 2010 Jun DISC
>A> 10MG A040858 001 Feb 26, 2010 Jun DISC
>D> AA 25MG A040858 002 Feb 26, 2010 Jun DISC >A> 25MG A040858 002 Feb 26, 2010 Jun DISC
>D> AA 50MG A040858 003 Feb 26, 2010 Jun DISC
>A> 50MG A040858 003 Feb 26, 2010 Jun DISC
>D> AA 100MG A040858 004 Feb 26, 2010 Jun DISC
>A>
HYDROXYUREA
100MG A040858 004 Feb 26, 2010 Jun DISC
CAPSULE; ORAL
HYDROXYUREA
>A> @ BARR LABS INC 250MG A075020 002 Jun 26, 2000 Jun CAHN
>A> 500MG A075020 001 Jul 30, 1998 Jun CAHN
>D> @ DURAMED PHARMS BARR 250MG A075020 002 Jun 26, 2000 Jun CAHN
Paee 9 of 19
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST CAPSULE; ORAL
HYDROXYUREA
>D> @ DURAMED PHARMS BARR
HYDROXYZINE HYDROCHLORIDE
500MG A075020 001 Jul 30, 1998 Jun CAHN
TABLET; ORAL
HYDROXYZINE HYDROCHLORIDE
>A> AB CARACO 10MG A040899 001 Jun 10, 2008 Jun CAHN >A> AB 25MG A040899 002 Jun 10, 2008 Jun CAHN >A> AB 50MG A040899 003 Jun 10, 2008 Jun CAHN >D> AB SUN PHARM INDS INC 10MG A040899 001 Jun 10, 2008 Jun CAHN >D> AB 25MG A040899 002 Jun 10, 2008 Jun CAHN >D>
>A>
AB
ICOSAPENT ETHYL
50MG A040899 003 Jun 10, 2008 Jun CAHN
>A> CAPSULE; ORAL
>A> VASCEPA
>A> + AMARIN PHARMS
IMIPRAMINE PAMOATE
1GM N202057 001 Jul 26, 2012 Jun NEWA
CAPSULE; ORAL
IMIPRAMINE PAMOATE
>A> AB MYLAN PHARMS INC EQ 75MG HCL A202338 001 Jun 28, 2013 Jun NEWA >A> AB EQ 100MG HCL A202338 002 Jun 28, 2013 Jun NEWA >A> AB EQ 125MG HCL A202338 003 Jun 28, 2013 Jun NEWA >A> AB
INDINAVIR SULFATE
EQ 150MG HCL A202338 004 Jun 28, 2013 Jun NEWA
CAPSULE; ORAL
CRIXIVAN
>D> MERCK SHARP DOHME EQ 100MG BASE NO20685 006 Apr 19, 2000 Jun DISC >A> 8
INDOMETHACIN
EQ 100MG BASE NO20685 006 Apr 19, 2000 Jun DISC
CAPSULE; ORAL
INDOMETHACIN
>A> AB CARACO 25MG A091401 001 Mar 28, 2013 Jun CAHN >A> AB 50MG A091401 002 Mar 28, 2013 Jun CAHN >D> AB SUN PHARM INDS INC 25MG A091401 001 Mar 28, 2013 Jun CAHN >D> AB
ISONIAZID
50MG A091401 002 Mar 28, 2013 Jun CAHN
TABLET; ORAL
ISONIAZID
>D> AA WATSON LABS 300MG A080521 001 Jun DISC >A> 300MG A080521 001 Jun DISC
ISOSORBIDE DINITRATE
TABLET; SUBLINGUAL
ISOSORBIDE DINITRATE
>D> AB WATSON LABS 2.5MG A086033 001 Feb 26, 1988 Jun DISC >A> 8 2.5MG A086033 001 Feb 26, 1988 Jun DISC >D> AB + 5MG A086031 001 Sep 29, 1987 Jun DISC >A> 0 5MG A086031 001 Sep 29, 1987 Jun DISC >D> AB WEST WARD 5MG A086055 001 Nov 02, 1987 Jun CRLD >A> AB + WEST WARD PHARM CORP 5MG A086055 001 Nov 02, 1987 Jun CRLD
Pa2e 10 of 19
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST
>D> >A>
>D> >A>
ISRADIPINE
NO20336
NO20336
NO20336 NO20336
001
001
002 002
Jun
Jun
Jun Jun
01,
01,
01, 01,
1994
1994
1994 1994
Jun
Jun
Jun Jun
DISC
DISC DISC
DISC
TABLET, EXTENDED RELEASE; ORAL
DYNACIRC CR
GLAXOSMITHKLINE LLC 5MG
@ 5MG
+ 10MG
@ 10MG
KETOROLAC TROMETHAMINE
INJECTABLE; INJECTION
KETOROLAC TROMETHAMINE
>D> AP LUITPOLD 15MG/ML A078145 001 Jan 14, 2008 Jun DISC >A> 8 15MG/ML A078145 001 Jan 14, 2008 Jun DISC >D> AP 30MG/ML A078145 002 Jan 14, 2008 Jun DISC >A> @ 30MG/ML
LAMOTRIGINE
A078145 002 Jan 14, 2008 Jun DISC
TABLET; ORAL
LAMOTRIGINE
>A> AB ALKEM LABS LTD 25MG A200694 001 Jun 14, 2013 Jun NEWA >A> AB 100MG A200694 002 Jun 14, 2013 Jun NEWA >A> AB 150MG A200694 003 Jun 14, 2013 Jun NEWA >A> AB 200MG
TABLET, EXTENDED RELEASE; ORAL
A200694 004 Jun 14, 2013 Jun NEWA
LAMOTRIGINE
>A> AB DR REDDYS LABS LTD 25MG A202383 001 Jun 19, 2013 Jun NEWA >A> AB 50MG A202383 002 Jun 19, 2013 Jun NEWA >A> AB 100MG A202383 003 Jun 19, 2013 Jun NEWA >A> AB 200MG A202383 004 Jun 19, 2013 Jun NEWA >A> AB 300MG A202383 005 Jun 19, 2013 Jun NEWA >A> AB WILSHIRE PHARMS INC 25MG A202887 001 Jun 17, 2013 Jun NEWA >A> AB 50MG A202887 002 Jun 17, 2013 Jun NEWA >A> AB 100MG A202887 003 Jun 17, 2013 Jun NEWA
>A> AB 200MG
LENALIDOMIDE
A202887 004 Jun 17, 2013 Jun NEWA
CAPSULE; ORAL
REVLIMID
>A>
>D>
CELGENE 20MG
LEPIRUDIN RECOMBINANT
NO21880 006 Jun 5, 2013 Jun NEWA
>D> INJECTABLE; INJECTION
>D> REFLUDAN
>D> + BAYER HLTHCARE 50MG/VIAL NO20807 001 Mar 6, 1998 Jun DISC >A> @ 50MG/VIAL
LEUCOVORIN CALCIUM
NO20807 001 Mar 06, 1998 Jun DISC
INJECTABLE; INJECTION
LEUCOVORIN CALCIUM PRESERVATIVE FREE
>0> AP LUITPOLD EQ 50MG BASE/VIAL A040338 001 Jan 31, 2001 Jun DISC >A> 9 EQ SONG BASE/VIAL
LEVETIRACETAM
• A040338 001 Jan 31, 2001 Jun DISC
INJECTABLE; IV (INFUSION)
LEVETIRACETAM
>A> AP SAGENT PHARMS 500MG/5ML (100MG/ML) A091627 001 Jun 26, 2013 Jun NEWA
Page 11 of 19
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST
>A>
>A>
>A>
AP
AP
AP
LEVOFLOXACIN
A200674 A200674
A200674
001
002
003
Jun
Jun
Jun
19,
19,
19,
2013
2013
2013
Jun
Jun
Jun
NEWA
NEWA NEWA
INJECTABLE; INJECTION
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
FRESENIUS KABI USA EQ 250MG/50ML (EQ 5MG/ML)
EQ 500MG/100ML (EQ 5MG/ML)
EQ 750MG/150ML (EQ 5MG/ML)
LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE
INJECTABLE; INJECTION
>D> ISOCAINE HYDROCHLORIDE W/ LEVONORDEFRIN
>D> AP NOVOCOL 0.05MG/ML;2% A084697 001 Jun DISC
>A> @ 0.05MG/ML;2% A084697 001 Jun DISC
SCANDONEST L
>0> AP DEPROCO 0.05MG/ML;2% A088388 001 Oct 10, 1984 Jun CRLD
>A> + 0.05MG/ML;2%
LIDOCAINE HYDROCHLORIDE
A088388 001 Oct 10, 1984 Jun CRLD
JELLY; TOPICAL
LIDOCAINE HYDROCHLORIDE
>D> AT TEVA PHARMS 2% A081318 001 Apr 29, 1993 Jun DISC
>A> @ TEVA PHARMS USA 2%
MEFLOQUINE HYDROCHLORIDE
A081318 001 Apr 29, 1993 Jun DISC
TABLET; ORAL
MEFLOQUINE HYDROCHLORIDE
>0> AB WEST WARD 250MG A077699 001 Apr 21, 2010 Jun DISC
>A> @ WEST WARD PHARM CORP 250MG
METAXALONE
A077699 001 Apr 21, 2010 Jun DISC
TABLET; ORAL
METAXALONE
>A> AB AMNEAL PHARMS 800MG
METFORMIN HYDROCHLORIDE
A203399 001 Jun 21, 2013 Jun NEWA
TABLET, EXTENDED RELEASE; ORAL
METFORMIN HYDROCHLORIDE
>D> AB TORRENT PHARMS 750MG A079226 001 Feb 18, 2010 Jun DISC
>A>
>D>
@ TORRENT PHARMS LTD 750MG
METHYL AMINOLEVULINATE HYDROCHLORIDE
A079226 001 Feb 18, 2010 Jun DISC
>D> CREAM; TOPICAL
>D> METVIXIA
>D> + GALDERMA LABS LP EQ 16.8% BASE NO21415 001 Jul 27, 2004 Jun DISC
>A> @ EQ 16.8% BASE
METHYLPHENIDATE HYDROCHLORIDE
NO21415 001 Jul 27, 2004 Jun DISC
TABLET, EXTENDED RELEASE; ORAL
CONCERTA
>D> JANSSEN PHARMS 18MG NO21121 001 Aug 01, 2000 Jun CTEC
>A> AB 18MG
METHYLPHENIDATE HYDROCHLORIDE
NO21121 001 Aug 01, 2000 Jun CTEC
>A> AB KUDCO IRELAND 18MG A091695 001 Jul 09, 2013 Jun NEWA
>A> AB 27MG
METOLAZONE
A091695 002 Jul 09, 2013 Jun NEWA
TABLET; ORAL
METOLAZONE
>D> AB TEVA 5MG A076833 001 Mar 01, 2004 Jun DISC
Page 12 of 19
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST
>A>
TABLET; ORAL
METOLAZONE
@ TEVA
METYROSINE
5MG A076833 001 Mar 01, 2004 Jun DISC
CAPSULE; ORAL
DEMSER
>A> + ATON PHARMA VPNA 250MG N017871 001 Jun CAHN
>D> + BIOVAIL TECHNOLOGIES 250MG N017871 001 Jun CAHN
MIDAZOLAM HYDROCHLORIDE
INJECTABLE; INJECTION
MIDAZOLAM HYDROCHLORIDE
>D> AP INTL MEDICATED EQ 1MG BASE/ML A076144 001 Jan 26, 2005 Jun DISC >A> @ EQ 1MG BASE/ML A076144 001 Jan 26, 2005 Jun DISC >0> AP EQ 5MG BASE/ML A076144 002 Jan 26, 2005 Jun DISC >A> @
MIRTAZAPINE
EQ 5MG BASE/ML A076144 002 Jan 26, 2005 Jun DISC
TABLET, ORALLY DISINTEGRATING; ORAL
MIRTAZAPINE
>D> AB ACTAVIS ELIZABETH 15MG A077959 001 Feb 14, 2011 Jun DISC >A> @ 15MG A077959 001 Feb 14, 2011 Jun DISC >0> AB 30MG A077959 002 Feb 14, 2011 Jun DISC >A> @ 30MG A077959 002 Feb 14, 2011 Jun DISC >D> AB 45MG A077959 003 Feb 14, 2011 Jun DISC >A> @
MYCOPHENOLATE MOFETIL
45MG A077959 003 Feb 14, 2011 Jun DISC
CAPSULE; ORAL
MYCOPHENOLATE MOFETIL
>A> AB ALKEM LABS LTD
NAFTIFINE HYDROCHLORIDE
250MG A200197 001 Jun 13, 2013 Jun NEWA
GEL; TOPICAL
NAFTIN
>A> + MERZ PHARMS
NELFINAVIR MESYLATE
2% N204286 001 Jun 27, 2013 Jun NEWA
>D> POWDER; ORAL
>0> VIRACEPT
>D> + AGOURON EQ 50MG BASE/SCOOPFUL NO20778 001 Mar 14, 1997 Jun DISC
>A> @
NORETHINDRONE
EQ 50MG BASE/SCOOPFUL NO20778 001 Mar 14, 1997 Jun DISC
TABLET; ORAL-28
NORETHINDRONE
>A> AB1 FAMY CARE LTD
OXYBUTYNIN
0.35MG A201483 001 Jun 24, 2013 Jun NEWA
GEL, METERED; TRANSDERMAL
>D> ANTUROL
>0>
>A>
+ WATSON LABS INC
GELNIQUE 3%
3% N202513 001 Dec 07, 2011 Jun CTNA
>A> + WATSON LABS INC 3% N202513 001 Dec 07, 2011 Jun CTNA
Page 13 of 19
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST
OXYBUTYNIN CHLORIDE
SYRUP; ORAL
OXYBUTYNIN CHLORIDE
>D> AA MIKART 5MG/5ML A075039 001 Jan 29, 1999 Jun DISC >A> @
OXYCODONE HYDROCHLORIDE
5MG/5ML A075039 001 Jan 29, 1999 Jun DISC
TABLET; ORAL
OXYCODONE HYDROCHLORIDE
>D> @ NESHER PHARMS 5MG A077290 001 Dec 08, 2005 Jun CMFD >A> AB 5MG A077290 001 Dec 08, 2005 Jun CMFD >0> @ 10MG A077290 002 Dec 08, 2005 Jun CMFD >A> AB 10MG A077290 002 Dec 08, 2005 Jun CMFD >D> @ 15MG A077290 003 Dec 08, 2005 Jun CMFD >A> AB 15MG A077290 003 Dec 08, 2005 Jun CMFD >D> @ 20MG A077290 004 Dec 08, 2005 Jun CMFD >A> AB 20MG A077290 004 Dec 08, 2005 Jun CMFD >0> @ 30MG A077290 005 Dec 08, 2005 Jun CMFD >A> AB
PAROXETINE MESYLATE
30MG A077290 005 Dec 08, 2005 Jun CMFD
>A> CAPSULE; ORAL
>A> BRISDELLE
>A> + NOVEN THERAP
PHYTONADIONE
EQ 7.5MG BASE N204516 001 Jun 28, 2013 Jun NEWA
TABLET; ORAL
MEPHYTON
>0> + VALEANT PHARMS 5MG N010104 003 Jun CAHN >A> + 5MG N010104 003 Jun CAHN
PINDOLOL
TABLET; ORAL
PINDOLOL
>D> AB MYLAN 5MG A074019 001 Sep 03, 1992 Jun CTEC >D> AB + 10MG A074019 002 Sep 03, 1992 Jun CTEC >A> MYLAN PHARMS INC 5MG A074019 001 Sep 03, 1992 Jun CTEC >A> + 10MG A074019 002 Sep 03, 1992 Jun CTEC >D> AB WATSON LABS 5MG A074437 001 Feb 27, 1995 Jun DISC >A> @ 5MG A074437 001 Feb 27, 1995 Jun DISC >ID> AB 10MG A074437 002 Feb 27, 1995 Jun DISC >A> @
PRAMLINTIDE ACETATE
10MG A074437 002 Feb 27, 1995 Jun DISC
INJECTABLE; SUBCUTANEOUS
SYMLIN
>D> AMYLIN PHARMS EQ 2.7MG BASE/2.7ML BASE/ML)
(EQ 1MG NO21332 003 Sep 25, 2007 Jun CRLD
>D> EQ 3MG BASE/5ML (EQ BASE/ML)
600MCG NO21332 001 Mar 16, 2005 Jun DISC
>A> + AMYLIN PHARMS LLC EQ 2.7MG BASE/2.7ML BASE/ML)
(EQ 1MG NO21332 003 Sep 25, 2007 Jun CRLD
>A> @ EQ 3MG BASE/5ML (EQ BASEPIL)
600MCG NO21332 001 Mar 16, 2005 Jun DISC
PRAZIQUANTEL
TABLET; ORAL
BILTRICIDE
>A> + BAYER HLTHCARE 600MG N018714 001 Dec 29, 1982 Jun CAHN >D> + BAYER PHARMA AG 600MG N018714 001 Dec 29, 1982 Jun CAHN
Pane 14 of 19
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST
>D>
>D>
>A> >A>
QUAZEPAM
7.5MG
15MG 7.5MG 15MG
N018708
N018708
N018708 N018708
003
001
003 001
Feb
Dec
Feb Dec
26,
27,
26, 27,
1987
1985
1987 1985
Jun
Jun
Jun Jun
CAHN
CAHN CAHN
CAHN
TABLET; ORAL
DORAL
@ QUESTCOR PHARMS
+ @ SCIECURE PHARMA INC
+
RANITIDINE HYDROCHLORIDE
GRANULE, EFFERVESCENT; ORAL
ZANTAC 150
>A> @ GLAXO GRP LTD EQ 150MG BASE/PACKET NO20251 002 Mar 31, 1994 Jun CAHN >D> 8 GLAXOSMITHKLINE
INJECTABLE; INJECTION
EQ 150MG BASE/PACKET NO20251 002 Mar 31, 1994 Jun CAHN
>D> ZANTAC IN PLASTIC CONTAINER
>D> + COVIS PHARMA EQ 1MG BASE/ML N019593 002 Sep 27, 1991 Jun DISC >A> 8 COVIS PHARMA SARL
SYRUP; ORAL
EQ 1MG BASE/ML N019593 002 Sep 27, 1991 Jun DISC
ZANTAC
>A> AA + GLAXO GRP LTD EQ 15MG BASE/ML N019675 001 Dec 30, 1988 Jun CAHN >D> AA + GLAXOSMITHKLINE
TABLET; ORAL
EQ 15MG BASE/ML N019675 001 Dec 30, 1988 Jun CAHN
ZANTAC 150
>A> AB GLAXO GRP LTD EQ 150MG BASE N018703 001 Jun 09, 1983 Jun CAHN >D> AB GLAXOSMITHKLINE
ZANTAC 300
EQ 150MG BASE N018703 001 Jun 09, 1983 Jun CAHN
>A> AB + GLAXO GRP LTD EQ 300MG BASE N018703 002 Dec 09, 1985 Jun CAHN >D> AB + GLAXOSMITHKLINE EQ 300MG BASE N018703 002 Dec 09, 1985 Jun CAHN
TABLET, EFFERVESCENT; ORAL
ZANTAC 150
>A> 8 GLAXO GRP LTD EQ 150MG BASE NO20251 001 Mar 31, 1994 Jun CAHN >D> @ GLAXOSMITHKLINE
ZANTAC 25
EQ 150MG BASE NO20251 001 Mar 31, 1994 Jun CAHN
>A> + GLAXO GRP LTD EQ 25MG BASE NO20251 003 Apr 01, 2004 Jun CAHN >D> + GLAXOSMITHKLINE
RASAGILINE MESYLATE
EQ 25MG BASE NO20251 003 Apr 01, 2004 Jun CAHN
TABLET; ORAL
AZILECT
>D> TEVA EQ 0.5MG BASE NO21641 001 May 16, 2006 Jun CFTG >A> AB EQ 0.5MG BASE NO21641 001 May 16, 2006 Jun CFTG
>0> + EQ 1MG BASE NO21641 002 May 16, 2006 Jun CFTG >A>
>A>
AB +
RASAGILINE MESYLATE
EQ 1MG BASE NO21641 002 May 16, 2006 Jun CFTG
>A> AB WATSON LABS INC EQ 0.5MG BASE A201823 001 Jul 01, 2013 Jun NEWA >A> AB
RILUZOLE
EQ 1MG BASE A201823 002 Jul 01, 2013 Jun NEWA
TABLET; ORAL
RILUZOLE
>A> AB APOTEX CORP 50MG A091300 001 Jun 18, 2013 Jun NEWA >A> AB GLENMARK GENERICS 50MG A091394 001 Jun 18, 2013 Jun NEWA
>A> AB MYLAN PHARMS INC 50MG A203042 001 Jul 01, 2013 Jun NEWA >A> AB SUN PHARM INDS LTD
RIZATRIPTAN BENZOATE
50MG A091417 001 Jun 18, 2013 Jun NEWA
TABLET; ORAL
RIZATRIPTAN BENZOATE
>A> AB INVAGEN PHARMS EQ 5MG BASE A204339 001 Jul 01, 2013 Jun NEWA
Page 15 of 19
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST TABLET; ORAL
RIZATRIPTAN BENZOATE
>A> AB INVAGEN PHARMS EQ 10MG BASE
TABLET, ORALLY DISINTEGRATING; ORAL
A204339 002 Jul 01, 2013 Jun NEWA
RIZATRIPTAN BENZOATE
>A> AB APOTEX INC EQ 5MG BASE A202477 001 Jul 01, 2013 Jun NEWA >A> AB EQ 10MG BASE A202477 002 Jul 01, 2013 Jun NEWA
>A> AB AUROBINDO PHARMA LTD EQ 5MG BASE A203062 001 Jul 01, 2013 Jun NEWA
>A> AB EQ 10MG BASE A203062 002 Jul 01, 2013 Jun NEWA >A> AB GLENMARK GENERICS EQ 5MG BASE A201914 001 Jul 01, 2013 Jun NEWA >A> AB EQ 10MG BASE A201914 002 Jul 01, 2013 Jun NEWA >A> AB NATCO PHARMA LTD EQ 5MG BASE A203478 001 Jul 01, 2013 Jun NEWA >A> AB EQ 10MG BASE A203478 002 Jul 01, 2013 Jun NEWA
>A> AB SANDOZ EQ 5MG BASE A078739 001 Jul 01, 2013 Jun NEWA >A> AB EQ 10MG BASE
SERTACONAZOLE NITRATE
A078739 002 Jul 01, 2013 Jun NEWA
CREAM; TOPICAL
ERTACZO
>D> + VALEANT INTL 2% NO21385 001 Dec 10, 2003 Jun CAHN >A> + VALEANT LUXEMBOURG 2%
SODIUM FLUORIDE F-18
NO21385 001 Dec 10, 2003 Jun CAHN
INJECTABLE; INTRAVENOUS
SODIUM FLUORIDE F-18
>A> + MCPRF 10-91.5MCl/ML A203605 001 Jun 28, 2013 Jun NEWA
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC ANHYDROUS
INJECTABLE; INJECTION
SODIUM PHOSPHATES IN PLASTIC CONTAINER
>D> HOSPIRA 142MG/ML;276MG/ML N018892 001 May 10, 1983 Jun CRLD
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS
INJECTABLE; INJECTION
SODIUM PHOSPHATES IN PLASTIC CONTAINER
>A> + HOSPIRA 142MG/ML;276MG/ML
SULFACETAMIDE SODIUM
N018892 001 May 10, 1983 Jun CRLD
OINTMENT; OPHTHALMIC
SULFACETAMIDE SODIUM
>D> AT FERA PHARMS 10% A080029 001 Jun CAHN >A> AT PERRIGO CO TENNESSEE 10% A080029 001 Jun CAHN
SULFAMETHOXAZOLE; TRIMETHOPRIM
TABLET; ORAL
SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH
>D> AB SANDOZ 800MG;160MG N018598 004 May 19, 1982 Jun DISC >A> B 800MG;160MG
TACROLIMUS
N018598 004 May 19, 1982 Jun DISC
OINTMENT; TOPICAL
PROTOPIC
>ID> ASTELLAS 0.03% N050777 001 Dec 08, 2000 Jun CRLD >A>
>D>
0.03%
TILUDRONATE DISODIUM
N050777 001 Dec 08, 2000 Jun CRLD
>0> TABLET; ORAL
>D> SKELID
>0> + SANOFI AVENTIS US EQ 200MG BASE NO20707 001 Mar 07, 1997 Jun DISC >A> @ EQ 200MG BASE NO20707 001 Mar 07, 1997 Jur
Pagel6of19
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST
TIMOLOL MALEATE
SOLUTION/DROPS; OPHTHALMIC
TIMOLOL MALEATE
>D> AT AKORN EQ 0.25% BASE A074515 001 Mar 25, 1997 Jun DISC
>A> @
TOPIRAMATE
EQ 0.25% BASE A074515 001 Mar 25, 1997 Jun DISC
TABLET; ORAL
TOPIRAMATE
>D> AB UPSHER SMITH 25MG A078499 001 Jan 07, 2010 Jun DISC
>A> @ 25MG A078499 001 Jan 07, 2010 Jun DISC >D> AB 50MG A078499 002 Jan 07, 2010 Jun DISC >A> 9 50MG A078499 002 Jan 07, 2010 Jun DISC >D> AB 100MG A078499 003 Jan 07, 2010 Jun DISC >A> 9 100MG A078499 003 Jan 07, 2010 Jun DISC >D> AB 200MG A078499 004 Jan 07, 2010 Jun DISC >A> 9
TOPOTECAN HYDROCHLORIDE
200MG A078499 004 Jan 07, 2010 Jun DISC
INJECTABLE; INJECTION
TOPOTECAN HYDROCHLORIDE
>A> AP ACCORD HLTHCARE
TRANEXAMIC ACID
EQ 4MG BASE/VIAL A202351 001 Jun 26, 2013 Jun NEWA
INJECTABLE; INJECTION
TRANEXAMIC ACID
>A> AP CUSTOPHARM INC
TRAZODONE HYDROCHLORIDE
100MG/ML A201580 001 Jun 14, 2013 Jun NEWA
TABLET, EXTENDED RELEASE; ORAL
OLEPTRO
>D> 8 ANGELINI LLC 150MG NO22411 001 Feb 02, 2010 Jun CMFD
>D> 9 300MG NO22411 002 Feb 02, 2010 Jun CMFD >A> + ANGELINI PHARMA 150MG NO22411 001 Feb 02, 2010 Jun CMFD >A>
>A> TREPROSTINIL
300MG NO22411 002 Feb 02, 2010 Jun CMFD
>A> INJECTABLE; IV (INFUSION)-SC
>A> REMODULIN
>A>
>D>
+ UNITED THERAP
TREPROSTINIL SODIUM
10MG/ML NO21272 004 May 21, 2002 Jun CAIN
>D> INJECTABLE; IV (INFUSION)-SC
>D> REMODULIN
>D> + UNITED THERAP
TRETINOIN
10MG/ML NO21272 004 May 21, 2002 Jun CAIN
CREAM; TOPICAL
RETIN-A
>A> AB + VALEANT BERMUDA 0.025% N019049 001 Sep 16, 1988 Jun CAHN
>A> AB1 + 0.05% N017522 001 Jun CAHN >A> AB + 0.1% N017340 001 Jun CAHN
>D> AB + VALEANT INTL 0.025% N019049 001 Sep 16, 1988 Jun CAHN
>D> AB1 + 0.05% N017522 001 Jun CAHN
>D> AB + 0.1% N017340 001 Jun CAHN
Page 17 of 19
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST
TRIMETHOPRIM
TABLET; ORAL TRIMETHOPRIM
>D> + TEVA 200MG A071259 001 Jun 18, 1987 Jun DISC >A> 8
VALPROIC ACID
200MG A071259 001 Jun 18, 1987 Jun DISC
>D> CAPSULE, DELAYED RELEASE; ORAL >D> STAVZOR >D> BANNER PHARMACAPS 125MG NO22152 001 Jul 29, 2008 Jun DISC >A> @ 125MG NO22152 001 Jul 29, 2008 Jun DISC >D> 250MG NO22152 002 Jul 29, 2008 Jun DISC >A> @ 250MG NO22152 002 Jul 29, 2008 Jun DISC >0> + 500MG NO22152 003 Jul 29, 2008 Jun DISC >A> @
WARFARIN SODIUM
500MG NO22152 003 Jul 29, 2008 Jun DISC
TABLET; ORAL
WARFARIN SODIUM >A> AB IPCA LABS LTD 1MG A200104 001 Jun 27, 2013 Jun NEWA >A> AB 2MG A200104 002 Jun 27, 2013 Jun NEWA >A> AB 2.5MG A200104 003 Jun 27, 2013 Jun NEWA >A> AB 3MG A200104 004 Jun 27, 2013 Jun NEWA >A> AB 4MG A200104 005 Jun 27, 2013 Jun NEWA >A> AB 5MG A200104 006 Jun 27, 2013 Jun NEWA >A> AB 6MG A200104 007 Jun 27, 2013 Jun NEWA >A> AB 7.5MG A200104 008 Jun 27, 2013 Jun NEWA >A> AB 10MG A200104 009 Jun 27, 2013 Jun NEWA
Page 18 of 19
ADDITIONS/DELETIONS FOR OTC DRUG PRODUCT LIST
OMEPRAZOLE; SODIUM BICARBONATE
>A> FOR SUSPENSION; ORAL
>A> ZEGERID OTC
>A> + MSD CONSUMER 20MG/PACKET;1.68GM/PACKET NO22283 001 Jun 17, 2013 Jun
CURRENT MONTH ADDS/DELETES LIST NOTE:
The List is sorted by Ingredient(s) and, within each grouping, by the Dosage Form; Route and then by trade name.
The individual product record contains the Therapeutic Equivalence Code, Reference Listed Drug symbol, applicant holder, strength(s), New Drug Application number, product number, and approval date. The last two columns describe the action. The Action Month is the CS month the action occurred. The OB Action is the type of change that has occurred.
New ingredient(s), new dosage form; route(s), new trade names, and new product additions are
preceded by >A> during the action month. The change month is the current CS month; the change code for new approvals is NEWA.
Changes to currently listed products will list two records. The deleted product record will be proceeded by >D>. The product record change addition being made will be preceded by >A>.
The change code description:
NEWA New drug product approval usually in the supplement month.
CAHN Applicant holder firm name has changed.
CAIN Change. There has been a change in the Ingredient(s) name. All products will be deleted under the old name and all products will be added under the changed ingredient(s) name.
CDFR Change. Dosage Form; Route of Administration.
CFTG Change. A first time generic for the innovator product. A TE Code is added.
CMFD Change. The product is moved from the Discontinued Section due to a change in marketing status.
CMS1 Change. Miscellaneous addition to list.
CMS2 Change. Miscellaneous deletion from list.
CPOT Change. Potency amount/unit.
CRLD Change. Reference Listed Drug.
CTEC Change. Therapeutic Equivalence Code.
CTNA Change. Trade Name.
DISC Discontinued. The Rx or OTC listed product is not being marketed and will be moved to the discontinued section in the next edition.
Page 19 of 19
top related