Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022273
Company: SANOFI AVENTIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OFORTA FLUDARABINE PHOSPHATE 10MG TABLET;ORAL Discontinued None No No
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
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

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