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Last Updated: January 29, 2026

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 seven 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. Nine 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

Medical Subject Heading (MeSH) Categories for 211831

Antineoplastic Agents, Alkylating
Myeloablative Agonists

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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