Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 008917
Company: PHARMACIA AND UPJOHN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CORTEF ACETATE HYDROCORTISONE ACETATE 2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** OINTMENT;TOPICAL Discontinued None Yes No
CORTEF ACETATE HYDROCORTISONE ACETATE 1% OINTMENT;TOPICAL 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
07/28/1953 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
07/05/1990 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

04/28/1987 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/28/1987 SUPPL-18 Manufacturing (CMC)-Formulation

Label is not available on this site.

10/14/1982 SUPPL-17 Labeling

Label is not available on this site.

03/19/1980 SUPPL-16 Labeling

Label is not available on this site.

10/11/1977 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

02/10/1977 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

10/12/1976 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

06/03/1976 SUPPL-11 Labeling

Label is not available on this site.

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