APPLICATION
ANDA076649
TYPE
ANDA
ORIGINAL APPROVAL
2007-09-05
LATEST ACTION
2013-05-07
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
2013-05-07Labeling · Supplement 8AP
2013-05-07Labeling · Supplement 9AP
2010-10-21Labeling · Supplement 7AP
2010-02-18Labeling · Supplement 6AP
2009-01-30Labeling · Supplement 4AP
2008-08-22Labeling · Supplement 3AP
2007-10-19Labeling · Supplement 1AP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.