General MedicationsINJECTIONStandard
FLUOROURACIL
FLUOROURACIL
Standard Dose
5GM/100ML (50MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview FLUOROURACIL is listed in Drugs@FDA under application 217676 (ANDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient FLUOROURACIL Form and strength INJECTABLE;INJECTION - 5GM/100ML (50MG/ML) Sponsor ALEMBIC Submission history Latest submission status date: 2026-02-05 00:00:00.
Structured Monograph
Clinical summary
Approval overview FLUOROURACIL is listed in Drugs@FDA under application 217676 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient FLUOROURACIL Form and strength INJECTABLE;INJECTION - 5GM/100ML (50MG/ML) Sponsor ALEMBIC Submission history Latest submission status date: 2026-02-05 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.