Last Updated: September 28, 2026

Details for New Drug Application (NDA): 205447

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NDA 205447 describes BENDAMUSTINE HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Apotex, Breckenridge, Dr Reddys, Eugia Pharma, Meitheal, Nang Kuang Pharm Co, Pharmobedient, Avyxa Holdings, Baxter Hlthcare Corp, and Hospira, and is included in twelve NDAs. It is available from seven suppliers. Additional details are available on the BENDAMUSTINE HYDROCHLORIDE profile page.

The generic ingredient in BENDAMUSTINE HYDROCHLORIDE is bendamustine hydrochloride. There is one drug master file entry for this compound. Twelve suppliers are listed for this compound. Additional details are available on the bendamustine hydrochloride profile page.

Summary for 205447

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

Medical Subject Heading (MeSH) Categories for 205447

Antineoplastic Agents, Alkylating

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	POWDER;INTRAVENOUS			Strength	25MG/VIAL
Approval Date:	Feb 14, 2023	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	POWDER;INTRAVENOUS			Strength	100MG/VIAL
Approval Date:	Feb 14, 2023	TE:		RLD:	No

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