← FDA DRUG APPROVALS

FDA NDA · NDA021798

BARACLUDE

entecavir

Sponsor: BRISTOL MYERS SQUIBB

APPLICATION
NDA021798
TYPE
NDA
ORIGINAL APPROVAL
2005-03-29
LATEST ACTION
2019-11-06
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

BARACLUDE · ReferencePrescription
ENTECAVIR 0.05MG/ML · SOLUTION · ORAL

Approval history

2019-11-06Labeling · Supplement 24 · standard — Letter ↗AP
2018-12-20Labeling · Supplement 23 · standard — Letter ↗AP
2018-06-22Labeling · Supplement 21 · standard — Letter ↗AP
2014-03-20Efficacy · Supplement 19 · priority — Label ↗AP
2013-12-19Labeling · Supplement 18 · standard — Label ↗AP
2013-06-18Manufacturing (CMC) · Supplement 17 · priorityAP
2012-10-12Efficacy · Supplement 16 · standard — Label ↗AP
2012-10-12Efficacy · Supplement 14 · standard — Label ↗AP
2010-12-28Labeling · Supplement 12 · standard — Label ↗AP
2010-10-15Efficacy · Supplement 11 · standard — Label ↗AP
2009-07-16Efficacy · Supplement 8 · unknown — Letter ↗AP
2009-02-25Labeling · Supplement 10 · standard — Letter ↗AP
2008-07-25Efficacy · Supplement 6 · standard — Label ↗AP
2008-06-03Labeling · Supplement 7 · standard — Letter ↗AP
2007-07-24Labeling · Supplement 3 · standard — Label ↗AP
2007-03-27Efficacy · Supplement 2 · unknown — Letter ↗AP
2007-02-23Efficacy · Supplement 1 · unknown — Label ↗AP
2005-03-29Type 3 - New Dosage Form · Original · priority — 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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →