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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 008126
Company: PHARMACIA AND UPJOHN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CORTISONE ACETATE CORTISONE ACETATE 25MG TABLET;ORAL Discontinued None No No
CORTISONE ACETATE CORTISONE ACETATE 25MG/ML INJECTABLE;INJECTION Discontinued None No No
CORTISONE ACETATE CORTISONE ACETATE 5MG TABLET;ORAL Discontinued None No No
CORTISONE ACETATE CORTISONE ACETATE 10MG 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
11/02/1951 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
12/21/1994 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

12/28/1993 SUPPL-35 Labeling

Label is not available on this site.

12/24/1991 SUPPL-34 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/08/1978 SUPPL-27 Labeling

Label is not available on this site.

05/16/1977 SUPPL-25 Manufacturing (CMC)-Formulation

Label is not available on this site.

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