Last Updated: September 24, 2026

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, Eugia Pharma, Hospira, Meitheal, Mylan Institutional, Nexus, Pharmascience Inc, Pharmobedient, Praxgen, Prinston Inc, and Shilpa, and is included in fifteen NDAs. It is available from seven suppliers. Additional details are available on the BUSULFAN profile page.

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

Summary for 205106

Tradename:	BUSULFAN
Applicant:	Praxgen
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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