General MedicationsSOLUTIONGeneric
SUGAMMADEX
SUGAMMADEX
Standard Dose
100MG/ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: None (Tentative Approval)
Summary
Approval overview SUGAMMADEX is listed in Drugs@FDA under application 218727 (ANDA).
Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient SUGAMMADEX Form and strength INJECTION;SOLUTION - 100MG/ML Sponsor HIKMA PHARMACEUTICALS USA INC Submission history Latest submission status date: 2025-06-27 00:00:00.
Structured Monograph
Clinical summary
Approval overview SUGAMMADEX is listed in Drugs@FDA under application 218727 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient SUGAMMADEX Form and strength INJECTION;SOLUTION - 100MG/ML Sponsor HIKMA PHARMACEUTICALS USA INC Submission history Latest submission status date: 2025-06-27 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: None (Tentative Approval)
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.