Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 011161
Company: ASTELLAS

Products on NDA 011161

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ARISTOCORT	TRIAMCINOLONE	2MG	TABLET;ORAL	Discontinued	None	No	No
ARISTOCORT	TRIAMCINOLONE	4MG	TABLET;ORAL	Discontinued	None	No	No
ARISTOCORT	TRIAMCINOLONE	1MG	TABLET;ORAL	Discontinued	None	No	No
ARISTOCORT	TRIAMCINOLONE	16MG	TABLET;ORAL	Discontinued	None	No	No
ARISTOCORT	TRIAMCINOLONE	8MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 011161

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/03/1957	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/17/1999	SUPPL-51	Manufacturing (CMC)		Label is not available on this site.
10/18/1994	SUPPL-50	Manufacturing (CMC)-Control		Label is not available on this site.
09/07/1993	SUPPL-49	Labeling		Label is not available on this site.
03/30/1994	SUPPL-48	Manufacturing (CMC)-Control		Label is not available on this site.
03/13/2009	SUPPL-47	Labeling		Label is not available on this site.
09/25/1986	SUPPL-46	Manufacturing (CMC)-Control		Label is not available on this site.
11/29/1986	SUPPL-45	Manufacturing (CMC)-Packaging		Label is not available on this site.
03/13/2009	SUPPL-44	Labeling		Label is not available on this site.
06/11/1982	SUPPL-43	Manufacturing (CMC)-Control		Label is not available on this site.
04/27/1981	SUPPL-42	Manufacturing (CMC)-Formulation		Label is not available on this site.
08/06/1979	SUPPL-40	Manufacturing (CMC)-Control		Label is not available on this site.
03/13/2009	SUPPL-39	Labeling		Label is not available on this site.