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FDA ANDA · ANDA077489

TRANDOLAPRIL

Sponsor: TEVA PHARMS

APPLICATION
ANDA077489
TYPE
ANDA
ORIGINAL APPROVAL
2006-12-12
LATEST ACTION
2015-08-31
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

2015-08-31Labeling · Supplement 7 · standardAP
2015-08-31Labeling · Supplement 10 · standardAP
2015-08-31Labeling · Supplement 8 · standardAP
2015-08-31Labeling · Supplement 6AP
2010-07-06Labeling · Supplement 5AP
2009-12-11Labeling · Supplement 4AP
2007-05-25Labeling · Supplement 2AP
2006-12-12Original — 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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