Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018709
Company: APOTHECON
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CAPOZIDE 25/15 CAPTOPRIL; HYDROCHLOROTHIAZIDE 25MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
CAPOZIDE 25/25 CAPTOPRIL; HYDROCHLOROTHIAZIDE 25MG;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
CAPOZIDE 50/15 CAPTOPRIL; HYDROCHLOROTHIAZIDE 50MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
CAPOZIDE 50/25 CAPTOPRIL; HYDROCHLOROTHIAZIDE 50MG;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
10/12/1984 ORIG-1 Approval Type 4 - New Combination STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/26/2009 SUPPL-35 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018709s035ltr.pdf
05/16/2006 SUPPL-33 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018709s033LTR.pdf
05/20/1997 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

06/03/1998 SUPPL-30 Labeling

Label is not available on this site.

06/26/1996 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

03/04/1996 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1996 SUPPL-27 Labeling

Label is not available on this site.

07/31/1996 SUPPL-26 Labeling

Label is not available on this site.

10/06/1995 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

05/12/1993 SUPPL-24 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/15/1992 SUPPL-23 Labeling

Label is not available on this site.

06/25/1992 SUPPL-22 Labeling

Label is not available on this site.

07/25/1994 SUPPL-21 Labeling

Label is not available on this site.

03/05/1992 SUPPL-20 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/10/1991 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

09/05/1990 SUPPL-18 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/21/1991 SUPPL-17 Labeling

Label is not available on this site.

09/27/1990 SUPPL-16 Labeling

Label is not available on this site.

05/03/1989 SUPPL-15 Labeling

Label is not available on this site.

10/19/1989 SUPPL-14 Labeling

Label is not available on this site.

06/22/1988 SUPPL-12 Labeling

Label is not available on this site.

10/06/1987 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

01/06/1987 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/24/1991 SUPPL-9 Efficacy-New Indication

Label is not available on this site.

01/17/1986 SUPPL-8 Labeling

Label is not available on this site.

08/02/1985 SUPPL-7 Labeling

Label is not available on this site.

07/15/1985 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/10/1986 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

07/03/1985 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/01/1985 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/07/1985 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/20/1984 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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