← FDA DRUG APPROVALS

FDA NDA · NDA202123

COMPLERA

emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate

Sponsor: GILEAD SCIENCES INC

APPLICATION
NDA202123
TYPE
NDA
ORIGINAL APPROVAL
2011-08-10
LATEST ACTION
2019-11-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

COMPLERA · ReferencePrescription
EMTRICITABINE 200MG, RILPIVIRINE HYDROCHLORIDE EQ 25MG BASE, TENOFOVIR DISOPROXIL FUMARATE 300MG · TABLET · ORAL

Approval history

2019-11-27Labeling · Supplement 31 · standard — Letter ↗AP
2018-10-31Efficacy · Supplement 29 · standard — Letter ↗AP
2017-04-07Labeling · Supplement 27 · standard — Label ↗AP
2016-03-09Manufacturing (CMC) · Supplement 26 · priorityAP
2016-02-23Labeling · Supplement 24 · standard — Label ↗AP
2016-02-23Efficacy · Supplement 21 · standard — Pediatric Medical Review ↗AP
2016-02-09Labeling · Supplement 23 · standard — Label ↗AP
2015-12-29Manufacturing (CMC) · Supplement 22 · priorityAP
2015-05-05Labeling · Supplement 20 · 901 required — Label ↗AP
2014-09-16Labeling · Supplement 18 · standard — Label ↗AP
2014-07-11Manufacturing (CMC) · Supplement 17 · priorityAP
2014-06-05Labeling · Supplement 16 · standard — Letter ↗AP
2013-12-13Efficacy · Supplement 12 · standard — Label ↗AP
2013-11-08Manufacturing (CMC) · Supplement 14 · priorityAP
2013-10-23Labeling · Supplement 15 · 901 required — Label ↗AP
2013-06-20Labeling · Supplement 11 · standard — Label ↗AP
2013-05-10Manufacturing (CMC) · Supplement 9 · priorityAP
2013-04-19Manufacturing (CMC) · Supplement 8 · priorityAP
2013-03-26Manufacturing (CMC) · Supplement 7 · priorityAP
2013-01-25Efficacy · Supplement 3 · standard — Label ↗AP
2012-08-10Labeling · Supplement 6 · 901 required — Letter ↗AP
2011-08-10Type 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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