Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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

• Summary Review

Products on NDA 022273

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022273

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/18/2008	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022273lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022273S000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022273_fludarabine_phosphate_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022273s000_SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/17/2009	SUPPL-1	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022273s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022273s001ltr.pdf

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