Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074363
Company: YAOPHARMA CO LTD
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
11/09/1995 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
03/27/2009 SUPPL-14 Labeling

Label is not available on this site.

12/05/2008 SUPPL-13 Labeling

Label is not available on this site.

10/29/2008 SUPPL-12 Labeling

Label is not available on this site.

05/14/2004 SUPPL-9 Labeling

Label is not available on this site.

03/25/2002 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

05/02/2001 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

04/22/1999 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

02/12/1998 SUPPL-5 Labeling

Label is not available on this site.

11/05/1997 SUPPL-4 Labeling

Label is not available on this site.

08/11/1997 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/05/1997 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

10/21/1996 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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