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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 217559

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NDA 217559 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 217559

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

Medical Subject Heading (MeSH) Categories for 217559

Antineoplastic Agents, Alkylating
Myeloablative Agonists

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL			Strength	15MG/VIAL
Approval Date:	Aug 20, 2024	TE:	AP	RLD:	No

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