General MedicationsINTRACAVITARY, INTRAVENOUS, INTRAVESICALStandard
THIOTEPA
THIOTEPA
Standard Dose
100MG/VIAL
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview THIOTEPA is listed in Drugs@FDA under application 216037 (ANDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient THIOTEPA Form and strength POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL - 100MG/VIAL Sponsor MEITHEAL Submission history Latest submission status date: 2023-12-26 00:00:00.
Structured Monograph
Clinical summary
Approval overview THIOTEPA is listed in Drugs@FDA under application 216037 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient THIOTEPA Form and strength POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL - 100MG/VIAL Sponsor MEITHEAL Submission history Latest submission status date: 2023-12-26 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.