Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022273
Company: SANOFI AVENTIS US

• Summary Review

Products on NDA 22273

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OFORTA	FLUDARABINE PHOSPHATE	10MG	TABLET;ORAL	Discontinued	None	No	No

Labels for NDA 022273

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/17/2009	SUPPL-1	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022273s001lbl.pdf
12/18/2008	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022273lbl.pdf