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FDA ANDA · ANDA078384

CARVEDILOL

Sponsor: REGCON HOLDINGS

APPLICATION
ANDA078384
TYPE
ANDA
ORIGINAL APPROVAL
2007-09-05
LATEST ACTION
2014-09-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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

Approval history

2014-09-17Manufacturing (CMC) · Supplement 2AP
2008-09-30Labeling · Supplement 1AP
2007-09-05Original — Letter ↗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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