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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020038
Company: GENZYME CORP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUDARA FLUDARABINE PHOSPHATE 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None Yes No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
04/18/1991 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/29/2010 SUPPL-33 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020038s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020038s033ltr.pdf
02/10/2009 SUPPL-32 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020038s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020038s032ltr.pdf
12/20/2007 SUPPL-31 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020038s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020038s031ltr.pdf
08/01/2003 SUPPL-28 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20038se8-028_fludara_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20038se8-028ltr.pdf
05/01/2002 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.
05/01/2002 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.
03/28/2002 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.
07/02/2002 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.
07/02/2002 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.
03/08/2000 SUPPL-20 Manufacturing (CMC)-Packaging

Label is not available on this site.
12/03/2001 SUPPL-19 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20038s19lbl.pdf
09/05/1996 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.
05/24/1999 SUPPL-17 Labeling

Label is not available on this site.
01/29/1996 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.
09/26/1994 SUPPL-14 Labeling

Label is not available on this site.
05/21/1993 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.
10/28/1992 SUPPL-11 Labeling

Label is not available on this site.
01/07/1993 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.
01/07/1993 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.
04/02/1992 SUPPL-6 Labeling

Label is not available on this site.
12/04/1991 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.
12/04/1991 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
07/29/2010 SUPPL-33 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020038s033lbl.pdf
02/10/2009 SUPPL-32 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020038s032lbl.pdf
12/20/2007 SUPPL-31 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020038s031lbl.pdf
08/01/2003 SUPPL-28 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20038se8-028_fludara_lbl.pdf
12/03/2001 SUPPL-19 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20038s19lbl.pdf
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