APPLICATION
ANDA078332
TYPE
ANDA
ORIGINAL APPROVAL
2007-09-05
LATEST ACTION
2020-03-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CARVEDILOLPrescription
CARVEDILOL 12.5MG · TABLET · ORAL
CARVEDILOLPrescription
CARVEDILOL 3.125MG · TABLET · ORAL
CARVEDILOLPrescription
CARVEDILOL 25MG · TABLET · ORAL
CARVEDILOLPrescription
CARVEDILOL 6.25MG · TABLET · ORAL
Approval history
2020-03-03Labeling · Supplement 24 · standardAP
2016-04-04Labeling · Supplement 21 · standardAP
2014-09-22Labeling · Supplement 8AP
2014-09-21Labeling · Supplement 14AP
2014-09-21Labeling · Supplement 12AP
2014-09-21Labeling · Supplement 10AP
2014-09-21Labeling · Supplement 5AP
2013-05-14Labeling · Supplement 4AP
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.