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FDA ANDA · ANDA077522

TRANDOLAPRIL

Sponsor: LUPIN

APPLICATION
ANDA077522
TYPE
ANDA
ORIGINAL APPROVAL
2007-06-12
LATEST ACTION
2019-08-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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

Approval history

2019-08-26Labeling · Supplement 14 · standardAP
2015-07-21Labeling · Supplement 8 · standardAP
2015-07-21Labeling · Supplement 6 · standardAP
2015-07-21Labeling · Supplement 10 · standardAP
2010-07-30Labeling · Supplement 5AP
2009-10-15Labeling · 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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