General MedicationsINJECTIONStandard
FLUMAZENIL
FLUMAZENIL
Standard Dose
0.5MG/5ML (0.1MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview FLUMAZENIL is listed in Drugs@FDA under application 090584 (ANDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient FLUMAZENIL Form and strength INJECTABLE;INJECTION - 0.5MG/5ML (0.1MG/ML) Sponsor SAGENT PHARMS Submission history Latest submission status date: 2015-05-01 00:00:00.
Structured Monograph
Clinical summary
Approval overview FLUMAZENIL is listed in Drugs@FDA under application 090584 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient FLUMAZENIL Form and strength INJECTABLE;INJECTION - 0.5MG/5ML (0.1MG/ML) Sponsor SAGENT PHARMS Submission history Latest submission status date: 2015-05-01 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.