← FDA DRUG APPROVALS

FDA NDA · NDA021500

EMTRIVA

emtricitabine

Sponsor: GILEAD

APPLICATION
NDA021500
TYPE
NDA
ORIGINAL APPROVAL
2003-07-02
LATEST ACTION
2018-12-10
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

EMTRIVA · ReferencePrescription
EMTRICITABINE 200MG · CAPSULE · ORAL

Approval history

2018-12-10Labeling · Supplement 29 · standard — Letter ↗AP
2017-04-07Labeling · Supplement 28 · standard — Label ↗AP
2014-03-25Manufacturing (CMC) · Supplement 25 · standardAP
2013-11-08Manufacturing (CMC) · Supplement 24 · standardAP
2013-04-02Labeling · Supplement 21 · standard — Letter ↗AP
2012-07-23Labeling · Supplement 19 · standard — Label ↗AP
2011-11-18Labeling · Supplement 18 · 901 required — Letter ↗AP
2008-05-16Efficacy · Supplement 11 · unknown — Letter ↗AP
2008-04-04Labeling · Supplement 10 · standard — Letter ↗AP
2006-12-22Labeling · Supplement 7 · standard — Letter ↗AP
2005-12-02Labeling · Supplement 3 · standard — Letter ↗AP
2005-06-13Labeling · Supplement 2 · standard — Letter ↗AP
2003-07-02Type 1 - New Molecular Entity · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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