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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208464
Company: GILEAD SCIENCES INC

Products on NDA 208464

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VEMLIDY	TENOFOVIR ALAFENAMIDE FUMARATE	EQ 25MG BASE	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208464

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/10/2016	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208464s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208464Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208464Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/27/2024	SUPPL-17	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208464s016s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/208464Orig1s016,s017ltr.pdf
03/27/2024	SUPPL-16	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208464s016s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/208464Orig1s016,s017ltr.pdf
12/14/2022	SUPPL-15	Manufacturing (CMC)-Facility	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208464Orig1s015Corrected_ltr.pdf
10/17/2022	SUPPL-14	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208464s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208464Orig1s014ltr.pdf
09/15/2021	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208464s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208464Orig1s013ltr.pdf
03/04/2021	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208464s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208464Orig1s012ltr.pdf
08/18/2020	SUPPL-11	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208464s010s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208464Orig1s010,s011ltr.pdf
08/18/2020	SUPPL-10	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208464s010s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208464Orig1s010,s011ltr.pdf
02/04/2020	SUPPL-8	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208464s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208464Orig1s008ltr.pdf
02/04/2019	SUPPL-7	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208464s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208464Orig1s007ltr.pdf
07/03/2018	SUPPL-4	Efficacy-Labeling Change With Clinical Data	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208464Orig1s004ltr.pdf
04/07/2017	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208464s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208464Orig1s001ltr.pdf

Labels for NDA 208464

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/27/2024	SUPPL-17	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208464s016s017lbl.pdf
03/27/2024	SUPPL-16	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208464s016s017lbl.pdf
10/17/2022	SUPPL-14	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208464s014lbl.pdf
09/15/2021	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208464s013lbl.pdf
03/04/2021	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208464s012lbl.pdf
08/18/2020	SUPPL-11	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208464s010s011lbl.pdf
08/18/2020	SUPPL-10	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208464s010s011lbl.pdf
02/04/2020	SUPPL-8	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208464s008lbl.pdf
02/04/2019	SUPPL-7	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208464s007lbl.pdf
04/07/2017	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208464s001lbl.pdf
11/10/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208464s000lbl.pdf

Therapeutic Equivalents for NDA 208464

VEMLIDY

TABLET;ORAL; EQ 25MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TENOFOVIR ALAFENAMIDE	TENOFOVIR ALAFENAMIDE FUMARATE	EQ 25MG BASE	TABLET;ORAL	Prescription	No	AB	214226	LUPIN LTD
TENOFOVIR ALAFENAMIDE FUMARATE	TENOFOVIR ALAFENAMIDE FUMARATE	EQ 25MG BASE	TABLET;ORAL	Prescription	No	AB	213867	APOTEX
VEMLIDY	TENOFOVIR ALAFENAMIDE FUMARATE	EQ 25MG BASE	TABLET;ORAL	Prescription	Yes	AB	208464	GILEAD SCIENCES INC

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