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FDA ANDA · ANDA078346

TRANDOLAPRIL

Sponsor: PHARMOBEDIENT

APPLICATION
ANDA078346
TYPE
ANDA
ORIGINAL APPROVAL
2008-04-28
LATEST ACTION
2020-04-14
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

2020-04-14Labeling · Supplement 4 · standardAP
2020-04-14Labeling · Supplement 5 · standardAP
2020-04-14Labeling · Supplement 3 · standardAP
2010-08-31Labeling · Supplement 2AP
2008-04-28Original — 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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