Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074827
Company: COSETTE

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CAPTOPRIL AND HYDROCHLOROTHIAZIDE CAPTOPRIL; HYDROCHLOROTHIAZIDE 25MG;15MG TABLET;ORAL Discontinued None No No
CAPTOPRIL AND HYDROCHLOROTHIAZIDE CAPTOPRIL; HYDROCHLOROTHIAZIDE 25MG;25MG TABLET;ORAL Discontinued None No No
CAPTOPRIL AND HYDROCHLOROTHIAZIDE CAPTOPRIL; HYDROCHLOROTHIAZIDE 50MG;25MG TABLET;ORAL Discontinued None No No
CAPTOPRIL AND HYDROCHLOROTHIAZIDE CAPTOPRIL; HYDROCHLOROTHIAZIDE 50MG;15MG 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
12/29/1997 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
10/30/2009 SUPPL-17 Labeling-Package Insert

Label is not available on this site.
11/29/2006 SUPPL-14 Labeling

Label is not available on this site.
08/30/2001 SUPPL-4 Manufacturing (CMC)-Facility

Label is not available on this site.
05/15/2000 SUPPL-3 Labeling

Label is not available on this site.
07/07/2000 SUPPL-2 Manufacturing (CMC)-Facility

Label is not available on this site.
03/22/1999 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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