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FDA ANDA · ANDA078320

TRANDOLAPRIL

Sponsor: INVAGEN PHARMS

APPLICATION
ANDA078320
TYPE
ANDA
ORIGINAL APPROVAL
2007-06-12
LATEST ACTION
2013-06-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

TRANDOLAPRILDiscontinued
TRANDOLAPRIL 2MG · TABLET · ORAL
TRANDOLAPRILDiscontinued
TRANDOLAPRIL 4MG · TABLET · ORAL
TRANDOLAPRILDiscontinued
TRANDOLAPRIL 1MG · TABLET · ORAL

Approval history

2013-06-10Labeling · Supplement 1AP
2007-06-12OriginalOther Important Information from FDAAP
VIEW ON DRUGS@FDA ↗

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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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