APPLICATION
ANDA077887
TYPE
ANDA
ORIGINAL APPROVAL
2007-09-07
LATEST ACTION
2013-05-07
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
2013-05-07Labeling · Supplement 6AP
2013-05-07Labeling · Supplement 4AP
2013-05-07Labeling · Supplement 3AP
2009-02-20Labeling · Supplement 2AP
2008-12-22Labeling · 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.
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