← FDA DRUG APPROVALS

FDA NDA · NDA203100

STRIBILD

elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate

Sponsor: GILEAD SCIENCES INC

APPLICATION
NDA203100
TYPE
NDA
ORIGINAL APPROVAL
2012-08-27
LATEST ACTION
2021-09-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

STRIBILD · ReferencePrescription
COBICISTAT 150MG, ELVITEGRAVIR 150MG, EMTRICITABINE 200MG, TENOFOVIR DISOPROXIL FUMARATE 300MG · TABLET · ORAL

Approval history

2021-09-09Labeling · Supplement 36 · standard — Letter ↗AP
2020-08-21Labeling · Supplement 35 · standard — Letter ↗AP
2019-02-06Labeling · Supplement 34 · standard — Label ↗AP
2018-11-02Labeling · Supplement 33 · standard — Label ↗AP
2018-08-07Labeling · Supplement 32 · standard — Label ↗AP
2017-08-30Labeling · Supplement 30 · standard — Letter ↗AP
2017-05-04Labeling · Supplement 29 · standard — Label ↗AP
2017-04-07Labeling · Supplement 28 · standard — Label ↗AP
2017-01-27Efficacy · Supplement 25 · priority — Label ↗AP
2016-09-15Labeling · Supplement 24 · 901 required — Letter ↗AP
2016-02-19Labeling · Supplement 21 · standard — Label ↗AP
2015-08-10Manufacturing (CMC) · Supplement 17 · standardAP
2015-07-28Labeling · Supplement 16 · standard — Label ↗AP
2015-06-08Manufacturing (CMC) · Supplement 15 · standardAP
2015-04-07Manufacturing (CMC) · Supplement 12 · standardAP
2014-12-17Efficacy · Supplement 11 · standard — Letter ↗AP
2014-08-28Efficacy · Supplement 10 · standard — Label ↗AP
2013-11-08Manufacturing (CMC) · Supplement 8 · standardAP
2013-10-23Labeling · Supplement 9 · 901 required — Label ↗AP
2013-10-16Manufacturing (CMC) · Supplement 7 · standardAP
2013-10-02Efficacy · Supplement 4 · standard — Letter ↗AP
2013-06-19Manufacturing (CMC) · Supplement 5 · standardAP
2013-05-03Manufacturing (CMC) · Supplement 2 · standardAP
2013-02-15Manufacturing (CMC) · Supplement 1 · standardAP
2012-08-27Type 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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