TEPYLUTE 10 mg/mL
thiotepa · INJECTION · Shorla Oncology Inc.
No Recall History
Plain English
TEPYLUTE is a injection containing thiotepa at 10 mg/mL, taken intravenous. Manufactured by Shorla Oncology Inc..
Key Facts
- Brand Name
- TEPYLUTE
- Generic Name
- thiotepa
- NDC Code (Product)
81927-106- Manufacturer
- Shorla Oncology Inc.
- Strength
- 10 mg/mL
- Dosage Form
- INJECTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA216984
- Drug Class
- Alkylating Drug [EPC]
- Marketing Start
- 03/31/2025
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
off label use1,095 reports
febrile neutropenia762 reports
mucosal inflammation758 reports
product use in unapproved indication589 reports
cytomegalovirus infection522 reports
drug ineffective517 reports
pyrexia489 reports
acute graft versus host disease443 reports
acute graft versus host disease in skin426 reports
infection414 reports
Frequently Asked Questions
What is TEPYLUTE used for?
TEPYLUTE contains thiotepa. It is a injection taken intravenous. Consult your doctor for specific uses.
Is TEPYLUTE a controlled substance?
TEPYLUTE is not classified as a controlled substance by the DEA.
What is the generic name for TEPYLUTE?
The generic name for TEPYLUTE is thiotepa. There are 11 other brand versions of thiotepa.
What is the NDC code for TEPYLUTE 10 mg/mL?
The NDC (National Drug Code) for TEPYLUTE 10 mg/mL is 81927-106, listed by Shorla Oncology Inc..