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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 215102

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NDA 215102 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 215102

Tradename:	BUSULFAN
Applicant:	Eugia Pharma
Ingredient:	busulfan
Patents:	0

Pharmacology for NDA: 215102

Mechanism of Action	Alkylating Activity

Medical Subject Heading (MeSH) Categories for 215102

Alkylating Agents
Antineoplastic Agents, Alkylating
Immunosuppressive Agents
Myeloablative Agonists

Suppliers and Packaging for NDA: 215102

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BUSULFAN	busulfan	INJECTABLE;INJECTION	215102	ANDA	Eugia US LLC	55150-395	55150-395-08	8 VIAL, SINGLE-DOSE in 1 CARTON (55150-395-08) / 10 mL in 1 VIAL, SINGLE-DOSE (55150-395-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	6MG/ML
Approval Date:	Jun 25, 2024	TE:		RLD:	No

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