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General MedicationsINJECTIONGeneric

FLUDARABINE PHOSPHATE

FLUDARABINE PHOSPHATE

Standard Dose
50MG/2ML (25MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview FLUDARABINE PHOSPHATE is listed in Drugs@FDA under application 203738 (ANDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient FLUDARABINE PHOSPHATE Form and strength INJECTABLE;INJECTION - 50MG/2ML (25MG/ML) Sponsor ACTAVIS LLC Submission history Latest submission status date: 2025-07-01 00:00:00.

Structured Monograph

Clinical summary

Approval overview FLUDARABINE PHOSPHATE is listed in Drugs@FDA under application 203738 (ANDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient FLUDARABINE PHOSPHATE Form and strength INJECTABLE;INJECTION - 50MG/2ML (25MG/ML) Sponsor ACTAVIS LLC Submission history Latest submission status date: 2025-07-01 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.