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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021023
Company: ALLERGAN

Products on NDA 021023

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RESTASIS	CYCLOSPORINE	0.05%	EMULSION; OPHTHALMIC	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021023

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/10/2003	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY	Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-023_Restasis.cfm

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