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Generic Drug Applicant Program Fee (the “ANDA Holder Program Fee”)

Determination Process The Food and Drug Administration (FDA or the Agency) must publish fiscal year (FY) 2018 fees in August of 2017. To help FDA meet that deadline, the Agency has published a list of all the approved abbreviated new drug applications (ANDAs) along with the holder of record for each ANDA on FDA’s website at http://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/default.htm. FDA is seeking general feedback on whether the information in this spreadsheet is accurate and complete, and is particularly interested in information that could be relevant to assessing whether two or more companies that are currently listed separately are considered to be affiliated for purposes of assessing the anticipated program fee. Please follow the instructions outlined in this document, if you plan to include affiliate information in your feedback, you may also include which Sponsor name is the Parent Company (the name that you would like all the affiliates to be listed under). For any questions about these instructions, and to submit your feedback, please contact FDA at CDERCollections@fda.hhs.gov.

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ANDA Holder Program Fee Determination Process

Second Posting

Revised spreadsheet with four tabs for your review

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1. Approved ANDAs NOT CLAIMED as of March 10, 2017 – This tab contains a list of all approved ANDAs that have NOT been claimed

and newly approved ANDAs. We encourage you to review this list and follow instructions on pages 10-29 on how to claim your approved ANDAs.

2. Approved ANDAs CLAIMED as of March 10, 2017 – This tab contains a list of all approved ANDAs that have been CLAIMED and

newly approved ANDAs. We encourage you to review this list and, if necessary, share your findings with FDA.

3. Pivot table – This tab contains a list of all approved ANDAs by unique sponsor’s name as of

March 10, 17. If you have not claimed your approved ANDAs, you can find instructions on how to claim your approved ANDAs on pages 10-29.

4. List -This tab contains details of all approved ANDAs as of March 10, 2017.

Tabs Content

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Tabs view and description

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This tab contains the number of approved ANDAs that have NOT been claimed by a sponsor or its affiliates. Column B: Number of approved ANDAs as of November 14, 2016 Column C: Number newly approved ANDAs from November 15, 2016 to March 10, 2017 Column D: Total number of approved ANDAs as of March 10, 2017 Column E: Applicable program tier

Approved ANDAs NOT CLAIMED

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Approved ANDAs CLAIMED

This tab contains the number of approved ANDAs that have been CLAIMED by a sponsor or its affiliates. Column B: Number of approved ANDAs as of November 14, 2016 Column C: Number newly approved ANDAs from November 15, 2016 to March 10, 2017 Column D: Total number of approved ANDAs as of March 10, 2017 Column E: Applicable program tier

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This tab contains a list of unique company names and their number of approved ANDAs as March 10, 2017. If you have NOT claimed your approved ANDAs as of March 10, 2017, you can find instructions on how to claim your approved ANDAs on pages 10-29.

Pivot (All approved ANDAs as of March 10, 2017)

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This tab contains details about all approved ANDAs as of March 10, 2017. You can use this list to verify details about your approved ANDAs.

List (Details about approved ANDAs as of March 10,2017)

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Instructions on how to search, claim, and submit your findings

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You Have Three Search Options

• Search for the Sponsor’s name using the Select Field.

• Search by typing the Sponsor’s name. • Search by ANDA number.

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Search Option 1 This option allows you to search for the Sponsor’s

name using the Select Field.

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1. After opening the Excel file, in the Company Name Heading (Row 6, Column A), click on the arrow at the right of the Excel cell (as shown by the red arrow above).

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2. After clicking on the arrow on the right of the Sponsor Name Heading (Row 6, Column A), a “Select Field” dialogue box will appear on your screen (as shown in Figure A above).

3. Click on the (Select All) checked box (red arrow above) to un-check all options. Figure B shows how this step will display on your screen.

Figure A Figure B

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4. After all options are un-checked (as shown in Figure C above), you may use the Scroll Bar (red arrow) in the Select Field Dialog Box to select the Sponsor Name(s) by clicking on the box(es) to the left of the Sponsor Name (blue arrow).

5. Figure D shows how your selection(s) will display on your screen. 6. Click OK to confirm your selection(s).

Figure C Figure D

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7. After clicking OK on the Select Field dialogue box your selection(s) will be displayed as shown above.

8. Review the selection(s) to ensure you have selected all the Sponsors you intended to select. If you wish to select additional Sponsors, repeat steps 3 to 6. Selection of additional Sponsors will not delete previous selections.

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9. You may expand each row by clicking on the “plus sign” box on left of the Sponsor name to view details of each ANDA held by each Sponsor (Column A, as shown by red arrow above).

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10. To view a complete list of ANDAs, double click on Grand Total number shown in Column B (as shown by the red arrow above) to display details regarding the approved ANDAs.

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11. After clicking on the Grand Total number, full ANDA details will be displayed in a new Sheet (red arrow), as shown above. 12. Review the ANDAs displayed. If any of the ANDAs do not belong to you, you can

delete those ANDAs from the list.

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Search Option 2 This option allows you to search by Sponsor’s

name.

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1. After opening the Excel file, in the Sponsor Name Heading (Row 6, Column A), click on the arrow at the right of the Excel cell (as shown by the red arrow above).

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2. After clicking on the arrow on the right of the Sponsor Name Heading (Row 6, Column A), a “Select Field” dialogue box will appear on your screen as shown above.

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3. In the Search field, type the Sponsor name and your selection will display as shown above (Figure A). Click OK to confirm your selection. 4. To select additional Sponsors, type the name in the Search field and select “Add current selection to filter” to save and add to current selection (Figure B). Click OK to confirm each selection. Repeat this step as necessary to identify additional Sponsors.

Figure A Figure B

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5. After you finish, your selection(s) will be displayed as shown above. 6. Review the records displayed to ensure that you have selected all the Sponsors you

intended to select. If you wish to select additional Sponsors, repeat steps 3 to 4. Selection of additional Sponsors will not delete previous selections.

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7. You may expand each row by clicking on the “plus sign” box on left of the Sponsor name to view details of each ANDA held by each Sponsor (Column A, as shown by red arrow above).

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8. To view a complete list of ANDAs, double click on Grand Total number shown in Column B (as shown by the red arrow above) to display details regarding the approved ANDAs.

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9. After clicking on the Grand Total number, full ANDA details will be displayed in a new Sheet (red arrow), as shown above.

10. Review the ANDAs displayed. If any of the ANDAs do not belong to you, you can delete those ANDAs from the list.

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Search Option 3 This option allows you to search by ANDA

number.

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Enter an ANDA number in the yellow highlighted cell (column B) then press Enter. Please note that this search option will provide you with only one ANDA detail at a time. You may compile a new list of approved ANDAs or add to a previous list from options 1 or 2.

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If you have any questions regarding these instructions, please email:

CDERCollections@fda.hhs.gov