Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 011835
Company: MERCK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDRODIURIL HYDROCHLOROTHIAZIDE 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
HYDRODIURIL HYDROCHLOROTHIAZIDE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
HYDRODIURIL HYDROCHLOROTHIAZIDE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
02/24/1959 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
01/10/2002 SUPPL-64 Manufacturing (CMC)

Label is not available on this site.

09/08/1997 SUPPL-62 Manufacturing (CMC)

Label is not available on this site.

09/09/1997 SUPPL-61 Manufacturing (CMC)-Control

Label is not available on this site.

11/05/1998 SUPPL-60 Labeling

Label is not available on this site.

02/08/1996 SUPPL-59 Manufacturing (CMC)-Formulation

Label is not available on this site.

11/29/1995 SUPPL-58 Manufacturing (CMC)

Label is not available on this site.

09/26/1994 SUPPL-57 Manufacturing (CMC)

Label is not available on this site.

02/16/1994 SUPPL-56 Labeling

Label is not available on this site.

06/29/1994 SUPPL-55 Labeling

Label is not available on this site.

10/28/1992 SUPPL-53 Labeling

Label is not available on this site.

10/28/1992 SUPPL-51 Labeling

Label is not available on this site.

10/28/1992 SUPPL-44 Efficacy-New Dosing Regimen

Label is not available on this site.

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