AntidiabeticsINJECTIONStandard
SEMGLEE
INSULIN GLARGINE-YFGN
Standard Dose
3ML(100UNITS/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview SEMGLEE is listed in Drugs@FDA under application 761201 (BLA).
Review priority: STANDARD Marketing status: Prescription Active ingredient INSULIN GLARGINE-YFGN Form and strength INJECTABLE;INJECTION - 3ML(100UNITS/ML) Sponsor MYLAN PHARMS INC Submission history Latest submission status date: 2024-11-25 00:00:00.
Structured Monograph
Clinical summary
Approval overview SEMGLEE is listed in Drugs@FDA under application 761201 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient INSULIN GLARGINE-YFGN Form and strength INJECTABLE;INJECTION - 3ML(100UNITS/ML) Sponsor MYLAN PHARMS INC Submission history Latest submission status date: 2024-11-25 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.