General MedicationsINTRAVENOUSGeneric
INFUGEM
GEMCITABINE HYDROCHLORIDE
Standard Dose
EQ 1700MG BASE/170ML (EQ 10MG BASE/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary
Approval overview INFUGEM is listed in Drugs@FDA under application 208313 (NDA).
Review priority: STANDARD Marketing status: Discontinued Active ingredient GEMCITABINE HYDROCHLORIDE Form and strength SOLUTION;INTRAVENOUS - EQ 1700MG BASE/170ML (EQ 10MG BASE/ML) Sponsor SUN PHARM Submission history Latest submission status date: 2024-09-24 00:00:00.
Structured Monograph
Clinical summary
Approval overview INFUGEM is listed in Drugs@FDA under application 208313 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient GEMCITABINE HYDROCHLORIDE Form and strength SOLUTION;INTRAVENOUS - EQ 1700MG BASE/170ML (EQ 10MG BASE/ML) Sponsor SUN PHARM Submission history Latest submission status date: 2024-09-24 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Discontinued
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.