Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 202079
Company: APOTEX INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CANDESARTAN CILEXETIL CANDESARTAN CILEXETIL 4MG TABLET;ORAL Discontinued None No No
CANDESARTAN CILEXETIL CANDESARTAN CILEXETIL 8MG TABLET;ORAL Discontinued None No No
CANDESARTAN CILEXETIL CANDESARTAN CILEXETIL 16MG TABLET;ORAL Discontinued None No No
CANDESARTAN CILEXETIL CANDESARTAN CILEXETIL 32MG 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
01/10/2014 ORIG-1 Approval Not Applicable

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/12/2016 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

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