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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 209150

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NDA 209150 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 209150

Tradename:	THIOTEPA
Applicant:	Hengrui Pharma
Ingredient:	thiotepa
Patents:	0

Pharmacology for NDA: 209150

Mechanism of Action	Alkylating Activity

Medical Subject Heading (MeSH) Categories for 209150

Antineoplastic Agents, Alkylating
Myeloablative Agonists

Suppliers and Packaging for NDA: 209150

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
THIOTEPA	thiotepa	INJECTABLE;INJECTION	209150	ANDA	Sagent Pharmaceuticals	25021-246	25021-246-02	1 VIAL in 1 CARTON (25021-246-02) / 1.5 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	15MG/VIAL
Approval Date:	May 4, 2018	TE:	AP	RLD:	No

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