Gilead Sciences, Inc. (Hogan Lovells US LLP) - Citizen Petition

This Other document was issued by the Food and Drug Administration (FDA)

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Gilead Sciences Inc Hogan Lovells US LLP Citizen Petition

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Authors: cder

Appendix A Glossary of Terms

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Tab 1 Exclusivity Summary

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Tab 2 Five Year and Three Year Exclusivity Request

Reason Restricted: This attachment is restricted to show metadata only because it contains confidential business information data.

Tab 3 Acknowledgement Letter to Gilead Sciences Inc NDA Approval Letter

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Tab 4 Five Year and Three Year Exclusivity Request

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Tab 5 FDA Guide

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Abstract: IND/NDA Drug Classification

ID: FDA-2013-P-0058-0001

Document Information

Date Posted: Jan 23, 2013
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Submitter Information

Country: United States
Submitter's Representative: Hogan Lovells US LLP
Category: Private Industry - C0003


Comments Received*
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Attached are comments on the Petition submitted on behalf of Novartis Pharmaceuticals Corporation (Novartis).

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