Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021719
Company: EISAI INC

Products on NDA 21719

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ARICEPT	DONEPEZIL HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Discontinued	None	Yes	No

Labels for NDA 021719

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/13/2006	SUPPL-1	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021719s001lbl.pdf
10/18/2004	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21719lbl.pdf