Last Updated: November 13, 2026

Details for New Drug Application (NDA): 210931

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NDA 210931 describes BUSULFAN, which is a drug marketed by Accord Hlthcare Inc, Actavis, Adaptis, Am Regent, Amneal, Apotex, Eugia Pharma, Hospira, Meitheal, Mylan Institutional, Nexus, Pharmascience Inc, Pharmobedient, Prinston Inc, and Quagen, 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 210931

Tradename:	BUSULFAN
Applicant:	Adaptis
Ingredient:	busulfan
Patents:	0

Medical Subject Heading (MeSH) Categories for 210931

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:	Apr 18, 2019	TE:	AP	RLD:	No

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