Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 011635
Company: MERCK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIUPRES-250 CHLOROTHIAZIDE; RESERPINE 250MG;0.125MG TABLET;ORAL Discontinued None No No
DIUPRES-500 CHLOROTHIAZIDE; RESERPINE 500MG;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
12/11/1958 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
12/16/1994 SUPPL-45 Labeling

Label is not available on this site.

03/16/1994 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

09/17/1992 SUPPL-43 Labeling

Label is not available on this site.

07/07/1994 SUPPL-42 Labeling

Label is not available on this site.

07/01/1988 SUPPL-41 Labeling

Label is not available on this site.

04/07/1988 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

08/26/1987 SUPPL-39 Labeling

Label is not available on this site.

12/31/1987 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

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