Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078438
Company: AUROBINDO PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRANDOLAPRIL TRANDOLAPRIL 1MG TABLET;ORAL Prescription AB No No
TRANDOLAPRIL TRANDOLAPRIL 2MG TABLET;ORAL Prescription AB No No
TRANDOLAPRIL TRANDOLAPRIL 4MG TABLET;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/12/2007 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/01/2019 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

10/01/2019 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

10/30/2015 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

04/24/2015 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

04/24/2015 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

04/24/2015 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

11/29/2011 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

11/29/2010 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

06/08/2009 SUPPL-2 Labeling

Label is not available on this site.

TRANDOLAPRIL

TABLET;ORAL; 1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TRANDOLAPRIL TRANDOLAPRIL 1MG TABLET;ORAL Prescription No AB 078438 AUROBINDO PHARMA
TRANDOLAPRIL TRANDOLAPRIL 1MG TABLET;ORAL Prescription No AB 078508 EPIC PHARMA
TRANDOLAPRIL TRANDOLAPRIL 1MG TABLET;ORAL Prescription No AB 077522 LUPIN
TRANDOLAPRIL TRANDOLAPRIL 1MG TABLET;ORAL Prescription No AB 077489 TEVA PHARMS

TABLET;ORAL; 2MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TRANDOLAPRIL TRANDOLAPRIL 2MG TABLET;ORAL Prescription No AB 078438 AUROBINDO PHARMA
TRANDOLAPRIL TRANDOLAPRIL 2MG TABLET;ORAL Prescription No AB 078508 EPIC PHARMA
TRANDOLAPRIL TRANDOLAPRIL 2MG TABLET;ORAL Prescription No AB 077522 LUPIN
TRANDOLAPRIL TRANDOLAPRIL 2MG TABLET;ORAL Prescription No AB 077489 TEVA PHARMS

TABLET;ORAL; 4MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TRANDOLAPRIL TRANDOLAPRIL 4MG TABLET;ORAL Prescription No AB 078438 AUROBINDO PHARMA
TRANDOLAPRIL TRANDOLAPRIL 4MG TABLET;ORAL Prescription No AB 078508 EPIC PHARMA
TRANDOLAPRIL TRANDOLAPRIL 4MG TABLET;ORAL Prescription No AB 077522 LUPIN
TRANDOLAPRIL TRANDOLAPRIL 4MG TABLET;ORAL Prescription No AB 077489 TEVA PHARMS

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