Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 080745
Company: ASTELLAS

Products on ANDA 080745

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ARISTOCORT	TRIAMCINOLONE ACETONIDE	0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	OINTMENT;TOPICAL	Discontinued	None	Yes	No
ARISTOCORT A	TRIAMCINOLONE ACETONIDE	0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	OINTMENT;TOPICAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 080745

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/28/1972	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
10/13/1989	SUPPL-26	Manufacturing (CMC)		Label is not available on this site.
10/13/1989	SUPPL-25	Labeling		Label is not available on this site.
10/13/1989	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
12/28/1983	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.