General MedicationsINTRAVENOUSStandard
GRAFAPEX
TREOSULFAN
Standard Dose
5GM/VIAL
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview GRAFAPEX is listed in Drugs@FDA under application 214759 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient TREOSULFAN Form and strength POWDER;INTRAVENOUS - 5GM/VIAL Sponsor MEDEXUS Submission history Latest submission status date: 2025-02-05 00:00:00.
Structured Monograph
Clinical summary
Approval overview GRAFAPEX is listed in Drugs@FDA under application 214759 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient TREOSULFAN Form and strength POWDER;INTRAVENOUS - 5GM/VIAL Sponsor MEDEXUS Submission history Latest submission status date: 2025-02-05 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.