Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 083016
Company: ASTELLAS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ARISTOCORT TRIAMCINOLONE ACETONIDE 0.1% CREAM;TOPICAL Discontinued None No No
ARISTOCORT A TRIAMCINOLONE ACETONIDE 0.1% CREAM;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
07/24/1972 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/08/1998 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

10/08/1998 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

10/08/1998 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

07/17/1997 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

04/14/1995 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

11/09/1989 SUPPL-44 Labeling

Label is not available on this site.

10/06/1989 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

10/06/1989 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

06/29/1992 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

02/02/1984 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

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