# TEPYLUTE

NDC: 81927-105
Generic name: thiotepa
Labeler / Manufacturer: Shorla Oncology Inc.
Product type: HUMAN PRESCRIPTION DRUG
Marketing category: New Drug Application (innovator)
Dosage form: INJECTION
Routes: INTRAVENOUS
Marketing started: 20250331

FDA application: NDA216984

## Active ingredients

- THIOTEPA: 10 mg/mL

## Pharmacological class

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## External sources

- openFDA: https://api.fda.gov/drug/ndc.json?search=product_ndc:"81927-105"
- FDA NDC Directory: https://www.accessdata.fda.gov/scripts/cder/ndc/dsp_searchresult.cfm?p_ndc=81927-105
- DailyMed: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=add44e98-a042-4e38-b870-beb36693805b