Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018102
Company: PHARMACIA AND UPJOHN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MEDROL METHYLPREDNISOLONE ACETATE 40MG/BOT ENEMA;RECTAL 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
12/21/1977 ORIG-1 Approval Type 2 - New Active Ingredient 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
11/19/1982 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

04/01/1981 SUPPL-2 Manufacturing (CMC)-Formulation

Label is not available on this site.

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