Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 007750
Company: MERCK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CORTONE CORTISONE ACETATE 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
12/04/1950 ORIG-1 Approval Type 3 - New Dosage Form 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
03/01/1996 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

08/18/1994 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

08/27/1993 SUPPL-25 Labeling

Label is not available on this site.

11/30/1989 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

05/16/1989 SUPPL-18 Labeling

Label is not available on this site.

03/02/1982 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

02/01/1980 SUPPL-13 Labeling

Label is not available on this site.

09/25/1979 SUPPL-12 Labeling

Label is not available on this site.

08/01/1979 SUPPL-11 Labeling

Label is not available on this site.

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