Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074483
Company: ACP NIMBLE
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
02/13/1996 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
02/26/2002 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

08/30/2001 SUPPL-13 Manufacturing (CMC)-Facility

Label is not available on this site.

04/11/2000 SUPPL-12 Labeling

Label is not available on this site.

07/07/2000 SUPPL-11 Manufacturing (CMC)-Facility

Label is not available on this site.

02/22/2000 SUPPL-10 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

07/12/1999 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

10/01/1997 SUPPL-8 Labeling

Label is not available on this site.

01/07/1998 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

01/28/1997 SUPPL-6 Labeling

Label is not available on this site.

04/10/1997 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

12/13/1996 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/13/1996 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

08/13/1996 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

08/13/1996 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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