Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018498
Company: ASTELLAS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CYCLOCORT AMCINONIDE 0.1% OINTMENT;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
11/13/1981 ORIG-1 Approval Type 3 - New Dosage Form 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-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/11/1999 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/04/1998 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

09/03/2002 SUPPL-8 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18498s8lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18498slr008ltr.pdf
08/09/1995 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

11/29/1991 SUPPL-6 Manufacturing (CMC)-Control

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)-Control

Label is not available on this site.

03/18/1982 SUPPL-1 Manufacturing (CMC)-Formulation

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/03/2002 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18498s8lbl.pdf

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