← FDA DRUG APPROVALS

FDA NDA · NDA207561

GENVOYA

elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide

Sponsor: GILEAD SCIENCES INC

APPLICATION
NDA207561
TYPE
NDA
ORIGINAL APPROVAL
2015-11-05
LATEST ACTION
2022-01-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

GENVOYA · ReferencePrescription
COBICISTAT 150MG, ELVITEGRAVIR 150MG, EMTRICITABINE 200MG, TENOFOVIR ALAFENAMIDE FUMARATE EQ 10MG BASE · TABLET · ORAL

Approval history

2022-01-07Efficacy · Supplement 29 · priority — Letter ↗AP
2021-09-13Labeling · Supplement 27 · standard — Label ↗AP
2021-03-04Labeling · Supplement 25 · standard — Label ↗AP
2020-12-02Labeling · Supplement 24 · standard — Letter ↗AP
2019-03-18Labeling · Supplement 23 · standard — Letter ↗AP
2018-12-10Efficacy · Supplement 18 · standard — Label ↗AP
2018-11-02Labeling · Supplement 20 · standard — Label ↗AP
2018-08-01Labeling · Supplement 17 · standard — Label ↗AP
2017-11-22Efficacy · Supplement 13 · standard — Label ↗AP
2017-09-25Efficacy · Supplement 14 · priority — Label ↗AP
2017-08-15Efficacy · Supplement 11 · standard — Label ↗AP
2017-04-07Labeling · Supplement 10 · standard — Label ↗AP
2017-02-15Efficacy · Supplement 4 · standard — Label ↗AP
2017-02-15Efficacy · Supplement 5 · standard — Label ↗AP
2016-12-07Efficacy · Supplement 2 · standard — Label ↗AP
2016-09-15Labeling · Supplement 7 · 901 required — Letter ↗AP
2016-09-07Efficacy · Supplement 1 · standard — Label ↗AP
2016-03-08Labeling · Supplement 3 · standard — Label ↗AP
2015-11-05Type 1 - New Molecular Entity and Type 4 - New Combination · Original · standard — Summary Review ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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