Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074896
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CAPTOPRIL AND HYDROCHLOROTHIAZIDE CAPTOPRIL; HYDROCHLOROTHIAZIDE 25MG;15MG TABLET;ORAL Prescription None No No
CAPTOPRIL AND HYDROCHLOROTHIAZIDE CAPTOPRIL; HYDROCHLOROTHIAZIDE 25MG;25MG TABLET;ORAL Prescription None No Yes
CAPTOPRIL AND HYDROCHLOROTHIAZIDE CAPTOPRIL; HYDROCHLOROTHIAZIDE 50MG;25MG TABLET;ORAL Prescription None No No
CAPTOPRIL AND HYDROCHLOROTHIAZIDE CAPTOPRIL; HYDROCHLOROTHIAZIDE 50MG;15MG TABLET;ORAL Prescription None No Yes
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
08/14/2006 SUPPL-7 Labeling

Label is not available on this site.

08/21/2002 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

09/05/2001 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

08/25/2000 SUPPL-2 Labeling

Label is not available on this site.

08/11/2000 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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