← FDA DRUG APPROVALS

FDA NDA · NDA021752

TRUVADA

emtricitabine and tenofovir disoproxil fumarate

Sponsor: GILEAD

APPLICATION
NDA021752
TYPE
NDA
ORIGINAL APPROVAL
2004-08-02
LATEST ACTION
2024-04-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

TRUVADA · ReferencePrescription
EMTRICITABINE 167MG, TENOFOVIR DISOPROXIL FUMARATE 250MG · TABLET · ORAL
TRUVADA · ReferencePrescription
EMTRICITABINE 100MG, TENOFOVIR DISOPROXIL FUMARATE 150MG · TABLET · ORAL
TRUVADA · ReferencePrescription
EMTRICITABINE 133MG, TENOFOVIR DISOPROXIL FUMARATE 200MG · TABLET · ORAL
TRUVADA · ReferencePrescription
EMTRICITABINE 200MG, TENOFOVIR DISOPROXIL FUMARATE 300MG · TABLET · ORAL

Approval history

2024-04-29Labeling · Supplement 64 · standard — Letter ↗AP
2023-10-11Manufacturing (CMC) · Supplement 63 — Label ↗AP
2020-06-23Labeling · Supplement 61 · standard — Label ↗AP
2019-07-01REMS · Supplement 60 — Letter ↗AP
2018-05-15Efficacy · Supplement 55 · priority — Letter ↗AP
2017-12-08REMS · Supplement 54AP
2017-06-08REMS · Supplement 52 — Letter ↗AP
2017-04-21Labeling · Supplement 53 · standard — Letter ↗AP
2016-03-10Efficacy · Supplement 47 · standard — Label ↗AP
2016-02-25Labeling · Supplement 50 · standard — Letter ↗AP
2014-07-11Manufacturing (CMC) · Supplement 45 · priorityAP
2014-06-18REMS · Supplement 44 — Letter ↗AP
2013-12-16Labeling · Supplement 43 · 901 required — Letter ↗AP
2013-11-27Manufacturing (CMC) · Supplement 33 · priorityAP
2013-11-08Manufacturing (CMC) · Supplement 40 · priorityAP
2013-10-23Labeling · Supplement 42 · 901 required — Letter ↗AP
2013-08-21Manufacturing (CMC) · Supplement 38 · priorityAP
2013-08-15Manufacturing (CMC) · Supplement 37 · priorityAP
2013-07-08Manufacturing (CMC) · Supplement 39 · priorityAP
2013-06-17Labeling · Supplement 35 · standard — Label ↗AP
2013-06-17Manufacturing (CMC) · Supplement 36 · priorityAP
2012-07-16Labeling · Supplement 31 · standard — Label ↗AP
2012-07-16Efficacy · Supplement 30 · priority — Summary Review ↗AP
2011-07-08Labeling · Supplement 27 · standard — Label ↗AP
2010-01-15Manufacturing (CMC) · Supplement 21 · priorityAP
2009-11-06Labeling · Supplement 19 · standard — Letter ↗AP
2008-11-04Labeling · Supplement 17 · standard — Letter ↗AP
2008-05-16Efficacy · Supplement 16 · unknown — Letter ↗AP
2007-05-21Labeling · Supplement 11 · standard — Letter ↗AP
2006-03-08Efficacy · Supplement 5 · standard — Label ↗AP
2005-10-05Labeling · Supplement 6 · standard — Label ↗AP
2005-03-25Labeling · Supplement 2 · standard — Label ↗AP
2004-08-02Type 4 - New Combination · Original · priority — Pediatric Medical 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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