Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 080750
Company: ASTELLAS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ARISTOCORT TRIAMCINOLONE ACETONIDE 0.1% OINTMENT;TOPICAL Discontinued None No No
ARISTOCORT A TRIAMCINOLONE ACETONIDE 0.1% OINTMENT;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
04/26/1972 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
07/16/1997 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

04/14/1995 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

10/13/1989 SUPPL-37 Labeling

Label is not available on this site.

10/13/1989 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

10/13/1989 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

10/13/1989 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

12/30/1983 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

03/25/1982 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

03/25/1982 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

03/25/1982 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

03/25/1982 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English