Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 011958
Company: MERCK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROPRES 25 HYDROCHLOROTHIAZIDE; RESERPINE 25MG;0.125MG TABLET;ORAL Discontinued None No No
HYDROPRES 50 HYDROCHLOROTHIAZIDE; RESERPINE 50MG;0.125MG 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
05/16/1974 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer 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
04/05/2002 SUPPL-57 Manufacturing (CMC)

Label is not available on this site.

12/16/1994 SUPPL-56 Labeling

Label is not available on this site.

05/23/1995 SUPPL-55 Labeling

Label is not available on this site.

03/16/1994 SUPPL-54 Manufacturing (CMC)

Label is not available on this site.

12/02/1993 SUPPL-53 Labeling

Label is not available on this site.

10/01/1992 SUPPL-52 Labeling

Label is not available on this site.

09/17/1992 SUPPL-51 Labeling

Label is not available on this site.

09/18/1991 SUPPL-50 Labeling

Label is not available on this site.

04/22/1988 SUPPL-49 Manufacturing (CMC)-Control

Label is not available on this site.

07/01/1988 SUPPL-48 Labeling

Label is not available on this site.

08/26/1987 SUPPL-46 Labeling

Label is not available on this site.

08/15/1988 SUPPL-45 Manufacturing (CMC)-Control

Label is not available on this site.

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