General MedicationsINTRAPERITONEALStandard
EXTRANEAL
ICODEXTRIN
Standard Dose
7.5GM/100ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview EXTRANEAL is listed in Drugs@FDA under application 021321 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient ICODEXTRIN Form and strength SOLUTION;INTRAPERITONEAL - 7.5GM/100ML Sponsor VANTIVE US HLTHCARE Submission history Latest submission status date: 2024-04-22 00:00:00.
Structured Monograph
Clinical summary
Approval overview EXTRANEAL is listed in Drugs@FDA under application 021321 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ICODEXTRIN Form and strength SOLUTION;INTRAPERITONEAL - 7.5GM/100ML Sponsor VANTIVE US HLTHCARE Submission history Latest submission status date: 2024-04-22 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.