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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 075547

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NDA 075547 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 075547

Tradename:	THIOTEPA
Applicant:	West-ward Pharms Int
Ingredient:	thiotepa
Patents:	0

Pharmacology for NDA: 075547

Mechanism of Action	Alkylating Activity

Medical Subject Heading (MeSH) Categories for 075547

Antineoplastic Agents, Alkylating
Myeloablative Agonists

Suppliers and Packaging for NDA: 075547

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
THIOTEPA	thiotepa	INJECTABLE;INJECTION	075547	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9309	0143-9309-01	1 VIAL in 1 BOX, UNIT-DOSE (0143-9309-01) / 1.5 mL in 1 VIAL
THIOTEPA	thiotepa	INJECTABLE;INJECTION	075547	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9565	0143-9565-01	1 VIAL in 1 BOX, UNIT-DOSE (0143-9565-01) / 1.5 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	15MG/VIAL
Approval Date:	Apr 2, 2001	TE:	AP	RLD:	No

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