Last Updated: June 24, 2026

Details for New Drug Application (NDA): 208536

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NDA 208536 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 seven 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. Nine suppliers are listed for this compound. Additional details are available on the busulfan profile page.

Summary for 208536

Tradename:	BUSULFAN
Applicant:	Mylan Institutional
Ingredient:	busulfan
Patents:	0

Medical Subject Heading (MeSH) Categories for 208536

Alkylating Agents
Antineoplastic Agents, Alkylating
Immunosuppressive Agents
Myeloablative Agonists

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	6MG/ML
Approval Date:	Nov 20, 2017	TE:	AP	RLD:	No

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