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FDA ANDA · ANDA078438

TRANDOLAPRIL

Sponsor: AUROBINDO PHARMA

APPLICATION
ANDA078438
TYPE
ANDA
ORIGINAL APPROVAL
2007-06-12
LATEST ACTION
2019-10-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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

Approval history

2019-10-01Labeling · Supplement 15 · standardAP
2019-10-01Labeling · Supplement 16 · standardAP
2015-10-30Labeling · Supplement 14 · standardAP
2015-04-24Labeling · Supplement 7AP
2015-04-24Labeling · Supplement 8 · standardAP
2015-04-24Labeling · Supplement 12 · standardAP
2011-11-29Labeling · Supplement 6AP
2010-11-29Labeling · Supplement 3AP
2009-06-08Labeling · Supplement 2AP
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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