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FDA NDA · NDA021449

HEPSERA

Sponsor: GILEAD

APPLICATION
NDA021449
TYPE
NDA
ORIGINAL APPROVAL
2002-09-20
LATEST ACTION
2018-12-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

HEPSERA · ReferenceDiscontinued
ADEFOVIR DIPIVOXIL 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2018-12-28Labeling · Supplement 24 · standard — Letter ↗AP
2014-02-20Manufacturing (CMC) · Supplement 22 · priorityAP
2013-10-04Manufacturing (CMC) · Supplement 21 · priorityAP
2012-11-29Labeling · Supplement 20 · standard — Label ↗AP
2012-02-29Labeling · Supplement 18 · unknown — Label ↗AP
2009-10-16Labeling · Supplement 16 · standard — Letter ↗AP
2008-05-27Labeling · Supplement 12 · standardAP
2007-12-19Efficacy · Supplement 11 · unknown — Letter ↗AP
2006-10-18Efficacy · Supplement 6 · unknown — Label ↗AP
2006-09-20Labeling · Supplement 9 · standard — Label ↗AP
2006-04-28Efficacy · Supplement 5 · unknown — Label ↗AP
2004-08-19Efficacy · Supplement 3 · unknown — Letter ↗AP
2002-09-20Type 1 - New Molecular Entity · Original · priority — Pediatric Medical Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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