Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 007110
Company: MERCK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CORTONE CORTISONE ACETATE 25MG/ML INJECTABLE;INJECTION Discontinued None No No
CORTONE CORTISONE ACETATE 50MG/ML INJECTABLE;INJECTION 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
06/13/1950 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

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-23 Manufacturing (CMC)

Label is not available on this site.

08/26/1993 SUPPL-21 Labeling

Label is not available on this site.

04/20/1994 SUPPL-20 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/16/1989 SUPPL-15 Labeling

Label is not available on this site.

12/09/1982 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/04/1982 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

08/15/1979 SUPPL-9 Labeling

Label is not available on this site.

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