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FDA ANDA · ANDA078240

CARVEDILOL

Sponsor: PLIVA HRVATSKA DOO

APPLICATION
ANDA078240
TYPE
ANDA
ORIGINAL APPROVAL
2007-10-30
LATEST ACTION
2007-10-30
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

2007-10-30OriginalAP
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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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