Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 011161
Company: ASTELLAS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ARISTOCORT TRIAMCINOLONE 2MG TABLET;ORAL Discontinued None No No
ARISTOCORT TRIAMCINOLONE 4MG TABLET;ORAL Discontinued None No No
ARISTOCORT TRIAMCINOLONE 1MG TABLET;ORAL Discontinued None No No
ARISTOCORT TRIAMCINOLONE 16MG TABLET;ORAL Discontinued None No No
ARISTOCORT TRIAMCINOLONE 8MG TABLET;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
12/03/1957 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
09/17/1999 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

10/18/1994 SUPPL-50 Manufacturing (CMC)-Control

Label is not available on this site.

09/07/1993 SUPPL-49 Labeling

Label is not available on this site.

03/30/1994 SUPPL-48 Manufacturing (CMC)-Control

Label is not available on this site.

09/25/1986 SUPPL-46 Manufacturing (CMC)-Control

Label is not available on this site.

11/29/1986 SUPPL-45 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/11/1982 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.

04/27/1981 SUPPL-42 Manufacturing (CMC)-Formulation

Label is not available on this site.

08/06/1979 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

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