Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022220
Company: ALLERGAN

• Summary Review

Products on NDA 022220

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRIVARIS	TRIAMCINOLONE ACETONIDE	8MG/0.1ML (8MG/0.1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022220

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/16/2008	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022220lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022220s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022220_trivaris_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/022220s000_SUMR.pdf

Labels for NDA 022220

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/16/2008	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022220lbl.pdf