General MedicationsINTRAVENOUSStandard
DEFITELIO
DEFIBROTIDE SODIUM
Standard Dose
200MG/2.5ML (80MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: PRIORITY Marketing status: Prescription
Summary
Approval overview DEFITELIO is listed in Drugs@FDA under application 208114 (NDA).
Review priority: PRIORITY Marketing status: Prescription Active ingredient DEFIBROTIDE SODIUM Form and strength SOLUTION;INTRAVENOUS - 200MG/2.5ML (80MG/ML) Sponsor JAZZ PHARMS INC Submission history Latest submission status date: 2016-03-30 00:00:00.
Structured Monograph
Clinical summary
Approval overview DEFITELIO is listed in Drugs@FDA under application 208114 (NDA). Review priority: PRIORITY Marketing status: Prescription Active ingredient DEFIBROTIDE SODIUM Form and strength SOLUTION;INTRAVENOUS - 200MG/2.5ML (80MG/ML) Sponsor JAZZ PHARMS INC Submission history Latest submission status date: 2016-03-30 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Prescription
- • Review priority: PRIORITY
Interaction Notes
- No interaction notes stored yet.