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General MedicationsINJECTIONStandard

FLUOROURACIL

FLUOROURACIL

Standard Dose
1GM/20ML (50MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription

Key Takeaways

  • Primary indication: Review priority: STANDARD Marketing status: Prescription
  • Approval overview FLUOROURACIL is listed in Drugs@FDA under application 210123 (ANDA).
  • Review priority: STANDARD Marketing status: Prescription Active ingredient FLUOROURACIL Form and strength INJECTABLE;INJECTION - 1GM/20ML (50MG/ML) Sponsor GLAND Submission history Latest submission status date: 2025-11-12 00:00:00.

Structured Monograph

Clinical summary

Approval overview FLUOROURACIL is listed in Drugs@FDA under application 210123 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient FLUOROURACIL Form and strength INJECTABLE;INJECTION - 1GM/20ML (50MG/ML) Sponsor GLAND Submission history Latest submission status date: 2025-11-12 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.