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Last Updated: November 12, 2024

Details for New Drug Application (NDA): 210448

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NDA 210448 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, Norvium Bioscience, Pharmascience Inc, Prinston Inc, and Shilpa, and is included in fifteen NDAs. It is available from ten 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. Thirteen suppliers are listed for this compound. Additional details are available on the busulfan profile page.

Summary for 210448

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

Medical Subject Heading (MeSH) Categories for 210448

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:	May 7, 2019	TE:	AP	RLD:	No

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