Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 010210
Company: SCHERING
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METIMYD PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM 0.5%;10% SUSPENSION/DROPS;OPHTHALMIC Discontinued None No No
METIMYD PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM 0.5%;10% OINTMENT;OPHTHALMIC 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
06/23/1965 ORIG-1 Approval Type 4 - New Combination 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
10/01/1999 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

08/21/1997 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

06/26/1997 SUPPL-21 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/13/1996 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

12/30/1994 SUPPL-19 Labeling

Label is not available on this site.

04/06/1989 SUPPL-18 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/03/1989 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

05/12/1987 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

03/16/1987 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

05/20/1986 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

04/28/1986 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

04/28/1986 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

03/11/1986 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

09/09/1984 SUPPL-10 Labeling

Label is not available on this site.

09/09/1984 SUPPL-9 Labeling

Label is not available on this site.

03/23/1988 SUPPL-8 Labeling

Label is not available on this site.

03/23/1988 SUPPL-7 Labeling

Label is not available on this site.

03/23/1988 SUPPL-6 Labeling

Label is not available on this site.

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