Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074737
Company: APOTEX
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CAPTOPRIL CAPTOPRIL 12.5MG TABLET;ORAL Discontinued None No No
CAPTOPRIL CAPTOPRIL 25MG TABLET;ORAL Discontinued None No No
CAPTOPRIL CAPTOPRIL 50MG TABLET;ORAL Discontinued None No No
CAPTOPRIL CAPTOPRIL 100MG 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
10/28/1998 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74737ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/16/2016 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

02/16/2016 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

01/20/2015 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

04/08/2011 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

11/13/2007 SUPPL-5 Labeling

Label is not available on this site.

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