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Last Updated: December 14, 2025

Details for New Drug Application (NDA): 207050

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NDA 207050 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 207050

Tradename:	BUSULFAN
Applicant:	Pharmascience Inc
Ingredient:	busulfan
Patents:	0

Pharmacology for NDA: 207050

Mechanism of Action	Alkylating Activity

Medical Subject Heading (MeSH) Categories for 207050

Alkylating Agents
Antineoplastic Agents, Alkylating
Immunosuppressive Agents
Myeloablative Agonists

Suppliers and Packaging for NDA: 207050

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BUSULFAN	busulfan	INJECTABLE;INJECTION	207050	ANDA	Sagent Pharmaceuticals	25021-241	25021-241-10	8 VIAL in 1 CARTON (25021-241-10) / 10 mL in 1 VIAL
BUSULFAN	busulfan	INJECTABLE;INJECTION	207050	ANDA	Pharmascience Inc.	51817-170	51817-170-01	8 VIAL in 1 PACKAGE (51817-170-01) / 10 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	6MG/ML
Approval Date:	Mar 24, 2017	TE:	AP	RLD:	No

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