Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078320
Company: INVAGEN PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRANDOLAPRIL TRANDOLAPRIL 1MG TABLET;ORAL Discontinued None No No
TRANDOLAPRIL TRANDOLAPRIL 2MG TABLET;ORAL Discontinued None No No
TRANDOLAPRIL TRANDOLAPRIL 4MG TABLET;ORAL Discontinued None 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
06/10/2013 SUPPL-1 Labeling-Container/Carton Labels

Label is not available on this site.

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