General MedicationsINTRAVENOUSStandard
TEPYLUTE
THIOTEPA
Standard Dose
15MG/1.5ML (10MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview TEPYLUTE is listed in Drugs@FDA under application 216984 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient THIOTEPA Form and strength SOLUTION;INTRAVENOUS - 15MG/1.5ML (10MG/ML) Sponsor SHORLA Submission history Latest submission status date: 2025-12-09 00:00:00.
Structured Monograph
Clinical summary
Approval overview TEPYLUTE is listed in Drugs@FDA under application 216984 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient THIOTEPA Form and strength SOLUTION;INTRAVENOUS - 15MG/1.5ML (10MG/ML) Sponsor SHORLA Submission history Latest submission status date: 2025-12-09 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.