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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208215
Company: GILEAD SCIENCES INC

Medication Guide

Summary Review

Products on NDA 208215

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DESCOVY	EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE	200MG;EQ 25MG BASE	TABLET;ORAL	Prescription	None	Yes	Yes
DESCOVY	EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE	120MG;EQ 15MG BASE	TABLET;ORAL	Prescription	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208215

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/04/2016	ORIG-1	Approval	Type 4 - New Combination	STANDARD; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208215s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208215Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208215Orig1_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208215Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/07/2022	SUPPL-20	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208215s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208215Orig1s020ltr.pdf
09/15/2021	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208215s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/0208215Orig1s019ltr.pdf
03/04/2021	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208215s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208215Orig1s017ltr.pdf
11/24/2020	SUPPL-14		Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208215Orig1s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208215Orig1s014ltr.pdf
10/03/2019	SUPPL-12	Efficacy-New Indication	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208215s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208215Orig1s012ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/208215Orig1s012.pdf
12/03/2019	SUPPL-11	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208215s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208215Orig1s011ltr.pdf
09/28/2017	SUPPL-5	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208215s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208215Orig1s005ltr.pdf
04/07/2017	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208215s001lbl.pdf

Labels for NDA 208215

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/07/2022	SUPPL-20	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208215s020lbl.pdf
09/15/2021	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208215s019lbl.pdf
03/04/2021	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208215s017lbl.pdf
11/24/2020	SUPPL-14	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208215Orig1s014lbl.pdf
12/03/2019	SUPPL-11	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208215s011lbl.pdf
10/03/2019	SUPPL-12	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208215s012lbl.pdf
09/28/2017	SUPPL-5	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208215s005lbl.pdf
04/07/2017	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208215s001lbl.pdf
04/04/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208215s000lbl.pdf

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