Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018116
Company: ASTELLAS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CYCLOCORT AMCINONIDE 0.025% CREAM;TOPICAL Discontinued None Yes No
CYCLOCORT AMCINONIDE 0.1% CREAM;TOPICAL Discontinued None Yes 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
10/18/1979 ORIG-1 Approval Type 1 - New Molecular Entity 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
06/16/1999 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/24/1998 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/23/1998 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

09/23/1998 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

02/02/1989 SUPPL-5 Labeling

Label is not available on this site.

03/13/2009 SUPPL-4 Labeling

Label is not available on this site.

08/26/1986 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/09/1985 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/13/2009 SUPPL-1 Labeling

Label is not available on this site.

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