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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 075698

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NDA 075698 describes THIOTEPA, which is a drug marketed by Beloteca, Dr Reddys, Fresenius Kabi Usa, Hengrui Pharma, Immunex, Penn Life, Teva Parenteral, West-ward Pharms Int, Gland Pharma Ltd, 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. Nine suppliers are listed for this compound. Additional details are available on the thiotepa profile page.

Summary for 075698

Tradename:	THIOTEPA
Applicant:	Fresenius Kabi Usa
Ingredient:	thiotepa
Patents:	0

Medical Subject Heading (MeSH) Categories for 075698

Antineoplastic Agents, Alkylating
Myeloablative Agonists

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	15MG/VIAL
Approval Date:	Sep 20, 2001	TE:		RLD:	No

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