← FDA DRUG APPROVALS

FDA NDA · NDA208464

VEMLIDY

tenofovir alafenamide

Sponsor: GILEAD SCIENCES INC

APPLICATION
NDA208464
TYPE
NDA
ORIGINAL APPROVAL
2016-11-10
LATEST ACTION
2024-03-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

VEMLIDY · ReferencePrescription
TENOFOVIR ALAFENAMIDE FUMARATE EQ 25MG BASE · TABLET · ORAL

Approval history

2024-03-27Efficacy · Supplement 16 · priority — Letter ↗AP
2024-03-27Efficacy · Supplement 17 · standard — Letter ↗AP
2022-12-14Manufacturing (CMC) · Supplement 15 — Letter ↗AP
2022-10-17Efficacy · Supplement 14 · priority — Letter ↗AP
2021-09-15Labeling · Supplement 13 · standard — Label ↗AP
2021-03-04Labeling · Supplement 12 · standard — Letter ↗AP
2020-08-18Efficacy · Supplement 10 · standard — Letter ↗AP
2020-08-18Efficacy · Supplement 11 · standard — Letter ↗AP
2020-02-04Efficacy · Supplement 8 · standard — Letter ↗AP
2019-02-04Efficacy · Supplement 7 · standard — Label ↗AP
2018-07-03Efficacy · Supplement 4 · standard — Letter ↗AP
2017-04-07Labeling · Supplement 1 · standard — Label ↗AP
2016-11-10Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
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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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