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FDA ANDA · ANDA078138

PERINDOPRIL ERBUMINE

Sponsor: ANI PHARMS

APPLICATION
ANDA078138
TYPE
ANDA
ORIGINAL APPROVAL
2009-11-10
LATEST ACTION
2009-11-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

PERINDOPRIL ERBUMINEDiscontinued
PERINDOPRIL ERBUMINE 8MG · TABLET · ORAL
PERINDOPRIL ERBUMINEDiscontinued
PERINDOPRIL ERBUMINE 2MG · TABLET · ORAL
PERINDOPRIL ERBUMINEDiscontinued
PERINDOPRIL ERBUMINE 4MG · TABLET · ORAL

Approval history

2009-11-10OriginalLetterAP
VIEW ON DRUGS@FDA ↗

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