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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 211831

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NDA 211831 describes THIOTEPA, which is a drug marketed by Dr Reddys, Fresenius Kabi Usa, Hengrui Pharma, Immunex, Penn Life, Regcon Holdings, Teva Parenteral, West-ward Pharms Int, Gland, Hikma, Meitheal, and MSN, and is included in thirteen NDAs. It is available from eight suppliers. Additional details are available on the THIOTEPA profile page.

The generic ingredient in THIOTEPA is thiotepa. There are eleven drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the thiotepa profile page.

Summary for 211831

Tradename:	THIOTEPA
Applicant:	Regcon Holdings
Ingredient:	thiotepa
Patents:	0

Pharmacology for NDA: 211831

Mechanism of Action	Alkylating Activity

Medical Subject Heading (MeSH) Categories for 211831

Antineoplastic Agents, Alkylating
Myeloablative Agonists

Suppliers and Packaging for NDA: 211831

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
THIOTEPA	thiotepa	INJECTABLE;INJECTION	211831	ANDA	Avenacy, LLC	83634-204	83634-204-02	1 VIAL, SINGLE-DOSE in 1 CARTON (83634-204-02) / 1.5 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	15MG/VIAL
Approval Date:	Dec 8, 2021	TE:	AP	RLD:	No

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