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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088819
Company: ASTELLAS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
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
09/29/2006 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
05/06/1998 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

05/06/1998 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

05/06/1998 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

05/06/1998 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

07/17/1997 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

04/14/1995 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

10/06/1989 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

03/09/1987 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

03/09/1987 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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