← FDA DRUG APPROVALS

FDA NDA · NDA208215

DESCOVY

emtricitabine and tenofovir alafenamide

Sponsor: GILEAD SCIENCES INC

APPLICATION
NDA208215
TYPE
NDA
ORIGINAL APPROVAL
2016-04-04
LATEST ACTION
2025-06-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

DESCOVY · ReferencePrescription
EMTRICITABINE 200MG, TENOFOVIR ALAFENAMIDE FUMARATE EQ 25MG BASE · TABLET · ORAL
DESCOVY · ReferencePrescription
EMTRICITABINE 120MG, TENOFOVIR ALAFENAMIDE FUMARATE EQ 15MG BASE · TABLET · ORAL

Approval history

2025-06-20Efficacy · Supplement 25 · standard — Label ↗AP
2025-06-20Efficacy · Supplement 23 · standard — Label ↗AP
2022-01-07Efficacy · Supplement 20 · priority — Letter ↗AP
2021-09-15Labeling · Supplement 19 · standard — Letter ↗AP
2021-03-04Labeling · Supplement 17 · standard — Letter ↗AP
2020-11-24Manufacturing (CMC) · Supplement 14 · standard — Letter ↗AP
2019-12-03Efficacy · Supplement 11 · standard — Letter ↗AP
2019-10-03Efficacy · Supplement 12 · priority — Label ↗AP
2017-09-28Efficacy · Supplement 5 · priority — Label ↗AP
2017-04-07Labeling · Supplement 1 · standard — Label ↗AP
2016-04-04Type 4 - New Combination · Original · standard — Label ↗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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