APPLICATION
ANDA077316
TYPE
ANDA
ORIGINAL APPROVAL
2007-09-05
LATEST ACTION
2025-07-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
CARVEDILOLDiscontinued
CARVEDILOL 12.5MG · TABLET · ORAL
CARVEDILOLDiscontinued
CARVEDILOL 3.125MG · TABLET · ORAL
CARVEDILOLDiscontinued
CARVEDILOL 25MG · TABLET · ORAL
CARVEDILOLDiscontinued
CARVEDILOL 6.25MG · TABLET · ORAL
Approval history
2025-07-23Labeling · Supplement 23 · standardAP
2020-03-03Labeling · Supplement 16 · standardAP
2016-04-04Labeling · Supplement 14 · standardAP
2014-09-19Labeling · Supplement 11 · standardAP
2013-06-13Labeling · Supplement 6AP
2011-04-21Labeling · Supplement 5AP
2011-02-14Labeling · Supplement 3AP
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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