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FDA ANDA · ANDA076373

CARVEDILOL

Sponsor: TEVA

APPLICATION
ANDA076373
TYPE
ANDA
ORIGINAL APPROVAL
2007-09-05
LATEST ACTION
2024-08-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

CARVEDILOLPrescription
CARVEDILOL 25MG · TABLET · ORAL
CARVEDILOLPrescription
CARVEDILOL 6.25MG · TABLET · ORAL
CARVEDILOLPrescription
CARVEDILOL 12.5MG · TABLET · ORAL
CARVEDILOLPrescription
CARVEDILOL 3.125MG · TABLET · ORAL

Approval history

2024-08-23Labeling · Supplement 19 · standardAP
2020-03-02Labeling · Supplement 16 · standardAP
2016-02-18Labeling · Supplement 15 · standardAP
2012-01-23Labeling · Supplement 12AP
2012-01-23Labeling · Supplement 10AP
2012-01-17Labeling · Supplement 5AP
2012-01-17Labeling · Supplement 6AP
2011-04-01Labeling · Supplement 9AP
2011-04-01Labeling · Supplement 8AP
2010-03-30Labeling · Supplement 7AP
2008-12-22Labeling · Supplement 4AP
2007-09-05Original — Letter ↗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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