← FDA DRUG APPROVALS

FDA NDA · NDA020297

COREG

carvedilol

Sponsor: WAYLIS THERAP

APPLICATION
NDA020297
TYPE
NDA
ORIGINAL APPROVAL
1995-09-14
LATEST ACTION
2023-07-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

COREG · ReferencePrescription
CARVEDILOL 12.5MG · TABLET · ORAL
COREG · ReferencePrescription
CARVEDILOL 6.25MG · TABLET · ORAL
COREG · ReferencePrescription
CARVEDILOL 25MG · TABLET · ORAL
COREG · ReferencePrescription
CARVEDILOL 3.125MG · TABLET · ORAL

Approval history

2023-07-26Labeling · Supplement 39 · standard — Letter ↗AP
2017-09-14Labeling · Supplement 38 · standard — Label ↗AP
2015-10-02Labeling · Supplement 37 · standard — Letter ↗AP
2011-07-06Labeling · Supplement 36 · unknown — Letter ↗AP
2011-01-25Labeling · Supplement 33 · unknown — Label ↗AP
2011-01-06Labeling · Supplement 34 · unknown — Letter ↗AP
2011-01-06Labeling · Supplement 35 · unknown — Letter ↗AP
2009-06-23Labeling · Supplement 29 · standard — Letter ↗AP
2008-12-19Labeling · Supplement 30 · standard — Letter ↗AP
2008-07-22Labeling · Supplement 28 · standard — Letter ↗AP
2007-02-23Efficacy · Supplement 22 · priority — Pediatric Written Request ↗AP
2006-12-20Labeling · Supplement 21 · standard — Letter ↗AP
2006-09-05Labeling · Supplement 20 · standard — Letter ↗AP
2006-08-28Efficacy · Supplement 18 · unknown — Label ↗AP
2005-08-16Labeling · Supplement 17 · standard — Letter ↗AP
2005-04-29Efficacy · Supplement 13 · standard — Label ↗AP
2003-09-29Labeling · Supplement 11 · standard — Letter ↗AP
2003-03-27Efficacy · Supplement 9 · priority — Review ↗AP
2002-11-08Manufacturing (CMC) · Supplement 8 · standardAP
2001-11-01Efficacy · Supplement 7 · standard — Review ↗AP
2001-07-10Manufacturing (CMC) · Supplement 6 · standardAP
2000-10-25Manufacturing (CMC) · Supplement 5 · standardAP
1999-09-08Labeling · Supplement 4 · standard — Review ↗AP
1998-07-28Labeling · Supplement 3 · standardAP
1997-05-29Efficacy · Supplement 1 · priorityAP
1996-05-20Manufacturing (CMC) · Supplement 2 · standardAP
1995-09-14Type 1 - New Molecular Entity · Original · standard — 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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