APPLICATION
ANDA076989
TYPE
ANDA
ORIGINAL APPROVAL
2007-09-05
LATEST ACTION
2020-03-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
CARVEDILOLDiscontinued
CARVEDILOL 25MG · TABLET · ORAL
CARVEDILOLDiscontinued
CARVEDILOL 6.25MG · TABLET · ORAL
CARVEDILOLDiscontinued
CARVEDILOL 12.5MG · TABLET · ORAL
CARVEDILOLDiscontinued
CARVEDILOL 3.125MG · TABLET · ORAL
Approval history
2020-03-03Labeling · Supplement 5 · standardAP
2016-03-29Labeling · Supplement 4 · standardAP
2008-11-13Labeling · Supplement 2AP
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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