Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 009766
Company: SCHERING
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METICORTEN PREDNISONE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
METICORTEN PREDNISONE 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
02/21/1955 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
08/26/1997 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

04/13/1994 SUPPL-14 Labeling

Label is not available on this site.

09/07/1993 SUPPL-13 Labeling

Label is not available on this site.

12/17/1992 SUPPL-12 Labeling

Label is not available on this site.

07/06/1992 SUPPL-11 Labeling

Label is not available on this site.

04/02/1987 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

08/27/1980 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

02/26/1979 SUPPL-6

Label is not available on this site.

01/25/1978 SUPPL-5 Labeling

Label is not available on this site.

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