Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 009900
Company: PHARMACIA AND UPJOHN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CORTEF HYDROCORTISONE CYPIONATE EQ 10MG BASE/5ML SUSPENSION;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
05/10/1955 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
12/01/1997 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

12/28/1993 SUPPL-23 Labeling

Label is not available on this site.

08/29/1990 SUPPL-22 Manufacturing (CMC)-Formulation

Label is not available on this site.

06/30/1982 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

06/04/1979 SUPPL-16 Labeling

Label is not available on this site.

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