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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 204230

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NDA 204230 describes BENDAMUSTINE HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Apotex, Breckenridge, Dr Reddys, Eugia Pharma, Meitheal, Nang Kuang Pharm Co, Pharmobedient, Baxter Hlthcare Corp, and Hospira, and is included in twelve NDAs. It is available from six suppliers. Additional details are available on the BENDAMUSTINE HYDROCHLORIDE profile page.

The generic ingredient in BENDAMUSTINE HYDROCHLORIDE is bendamustine hydrochloride. There are twenty-three drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the bendamustine hydrochloride profile page.

Summary for 204230

Tradename:	BENDAMUSTINE HYDROCHLORIDE
Applicant:	Apotex
Ingredient:	bendamustine hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 204230

Antineoplastic Agents, Alkylating

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	POWDER;INTRAVENOUS			Strength	25MG/VIAL
Approval Date:	Jun 5, 2023	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	POWDER;INTRAVENOUS			Strength	100MG/VIAL
Approval Date:	Jun 5, 2023	TE:		RLD:	No

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