Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 083017
Company: ASTELLAS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ARISTOCORT TRIAMCINOLONE ACETONIDE 0.025% CREAM;TOPICAL Discontinued None No No
ARISTOCORT A TRIAMCINOLONE ACETONIDE 0.025% 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
07/26/1972 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
06/29/1992 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

04/16/1987 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

04/16/1987 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

02/02/1984 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

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