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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208351
Company: GILEAD SCIENCES INC

Products on NDA 208351

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ODEFSEY	EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE	200MG;EQ 25MG BASE;EQ 25MG BASE	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208351

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/01/2016	ORIG-1	Approval	Type 4 - New Combination	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208351s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208351Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208351Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/10/2021	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208351s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208351Orig1s013ltr.pdf
03/04/2021	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208351s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208351Orig1s011ltr.pdf
12/03/2019	SUPPL-10	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208351s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208351Orig1s010ltr.pdf
10/31/2018	SUPPL-6	Efficacy-New Patient Population, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208351s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208351Orig1s006ltr.pdf
08/21/2017	SUPPL-3	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208351s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208351Orig1s002s003ltr.pdf
08/21/2017	SUPPL-2	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208351s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208351Orig1s002s003ltr.pdf
04/07/2017	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208351s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208351Orig1s001ltr.pdf

Labels for NDA 208351

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/10/2021	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208351s013lbl.pdf
03/04/2021	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208351s011lbl.pdf
12/03/2019	SUPPL-10	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208351s010lbl.pdf
10/31/2018	SUPPL-6	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208351s006lbl.pdf
10/31/2018	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208351s006lbl.pdf
08/21/2017	SUPPL-3	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208351s002s003lbl.pdf
08/21/2017	SUPPL-2	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208351s002s003lbl.pdf
04/07/2017	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208351s001lbl.pdf
03/01/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208351s000lbl.pdf

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