← FDA DRUG APPROVALS

FDA NDA · NDA208351

ODEFSEY

emtricitabine, rilpivirine hydrochloride, and tenofovir alafenamide

Sponsor: GILEAD SCIENCES INC

APPLICATION
NDA208351
TYPE
NDA
ORIGINAL APPROVAL
2016-03-01
LATEST ACTION
2025-02-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ODEFSEY · ReferencePrescription
EMTRICITABINE 200MG, RILPIVIRINE HYDROCHLORIDE EQ 25MG BASE, TENOFOVIR ALAFENAMIDE FUMARATE EQ 25MG BASE · TABLET · ORAL

Approval history

2025-02-19Efficacy · Supplement 15 · standard — Label ↗AP
2025-02-19Efficacy · Supplement 14 · standard — Label ↗AP
2021-09-10Labeling · Supplement 13 · standard — Label ↗AP
2021-03-04Labeling · Supplement 11 · standard — Letter ↗AP
2019-12-03Efficacy · Supplement 10 · standard — Letter ↗AP
2018-10-31Efficacy · Supplement 6 · standard — Letter ↗AP
2017-08-21Efficacy · Supplement 2 · standard — Label ↗AP
2017-08-21Efficacy · Supplement 3 · standard — Label ↗AP
2017-04-07Labeling · Supplement 1 · standard — Label ↗AP
2016-03-01Type 4 - New Combination · Original · priority — 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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