General MedicationsINJECTIONStandard
FOMEPIZOLE
FOMEPIZOLE
Standard Dose
1.5GM/1.5ML (1GM/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview FOMEPIZOLE is listed in Drugs@FDA under application 216791 (ANDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient FOMEPIZOLE Form and strength INJECTABLE;INJECTION - 1.5GM/1.5ML (1GM/ML) Sponsor GLAND Submission history Latest submission status date: 2023-07-06 00:00:00.
Structured Monograph
Clinical summary
Approval overview FOMEPIZOLE is listed in Drugs@FDA under application 216791 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient FOMEPIZOLE Form and strength INJECTABLE;INJECTION - 1.5GM/1.5ML (1GM/ML) Sponsor GLAND Submission history Latest submission status date: 2023-07-06 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.