General MedicationsINTRAVENOUSStandard
TEMODAR
TEMOZOLOMIDE
Standard Dose
100MG/VIAL
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview TEMODAR is listed in Drugs@FDA under application 022277 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient TEMOZOLOMIDE Form and strength POWDER;INTRAVENOUS - 100MG/VIAL Sponsor MERCK SHARP DOHME Submission history Latest submission status date: 2023-09-14 00:00:00.
Structured Monograph
Clinical summary
Approval overview TEMODAR is listed in Drugs@FDA under application 022277 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient TEMOZOLOMIDE Form and strength POWDER;INTRAVENOUS - 100MG/VIAL Sponsor MERCK SHARP DOHME Submission history Latest submission status date: 2023-09-14 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.