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FDA ANDA · ANDA077805

TRANDOLAPRIL

Sponsor: WATSON LABS

APPLICATION
ANDA077805
TYPE
ANDA
ORIGINAL APPROVAL
2007-06-12
LATEST ACTION
2025-05-06
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

2025-05-06Labeling · Supplement 10 · standardAP
2015-06-22Labeling · Supplement 6 · standardAP
2015-06-22Labeling · Supplement 9 · standardAP
2010-04-29Labeling · Supplement 3AP
2007-06-12Original — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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