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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 205106

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NDA 205106 describes BUSULFAN, which is a drug marketed by Accord Hlthcare Inc, Actavis, Am Regent, Amneal, Apotex, Arthur Grp, Eugia Pharma, Hospira, Meitheal, Mylan Institutional, Nexus, Pharmascience Inc, Pharmobedient, Prinston Inc, and Shilpa, and is included in fifteen NDAs. It is available from nine suppliers. Additional details are available on the BUSULFAN profile page.

The generic ingredient in BUSULFAN is busulfan. There are ten drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the busulfan profile page.

Summary for 205106

Tradename:	BUSULFAN
Applicant:	Arthur Grp
Ingredient:	busulfan
Patents:	0

Medical Subject Heading (MeSH) Categories for 205106

Alkylating Agents
Antineoplastic Agents, Alkylating
Immunosuppressive Agents
Myeloablative Agonists

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	6MG/ML
Approval Date:	Sep 21, 2018	TE:		RLD:	No

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