APPLICATION
ANDA077346
TYPE
ANDA
ORIGINAL APPROVAL
2007-09-05
LATEST ACTION
2016-06-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
CARVEDILOLDiscontinued
CARVEDILOL 25MG · TABLET · ORAL
CARVEDILOLDiscontinued
CARVEDILOL 6.25MG · TABLET · ORAL
CARVEDILOLDiscontinued
CARVEDILOL 3.125MG · TABLET · ORAL
CARVEDILOLDiscontinued
CARVEDILOL 12.5MG · TABLET · ORAL
Approval history
2016-06-01Labeling · Supplement 30 · standardAP
2016-06-01Labeling · Supplement 29 · standardAP
2015-04-06Labeling · Supplement 5AP
2013-05-10Labeling · Supplement 15AP
2013-05-10Labeling · Supplement 11AP
2011-01-31Labeling · Supplement 8AP
2009-01-15Labeling · Supplement 4AP
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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