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General MedicationsINJECTIONGeneric

FLUDARA

FLUDARABINE PHOSPHATE

Standard Dose
50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Max Dose
Refer to approved labeling
Primary Use
Review priority: PRIORITY Marketing status: Discontinued
Summary

Approval overview FLUDARA is listed in Drugs@FDA under application 020038 (NDA).

Review priority: PRIORITY Marketing status: Discontinued Active ingredient FLUDARABINE PHOSPHATE Form and strength INJECTABLE;INJECTION - 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor GENZYME CORP Submission history Latest submission status date: 2010-07-29 00:00:00.

Structured Monograph

Clinical summary

Approval overview FLUDARA is listed in Drugs@FDA under application 020038 (NDA). Review priority: PRIORITY Marketing status: Discontinued Active ingredient FLUDARABINE PHOSPHATE Form and strength INJECTABLE;INJECTION - 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor GENZYME CORP Submission history Latest submission status date: 2010-07-29 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: PRIORITY

Interaction Notes

  • No interaction notes stored yet.
FLUDARA (FLUDARABINE PHOSPHATE) | Drug Monograph | MedicHelpline