You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 14, 2025

Details for New Drug Application (NDA): 208536

✉ Email this page to a colleague

« Back to Dashboard

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 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 208536

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

Pharmacology for NDA: 208536

Mechanism of Action	Alkylating Activity

Medical Subject Heading (MeSH) Categories for 208536

Alkylating Agents
Antineoplastic Agents, Alkylating
Immunosuppressive Agents
Myeloablative Agonists

Suppliers and Packaging for NDA: 208536

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BUSULFAN	busulfan	INJECTABLE;INJECTION	208536	ANDA	Mylan Institutional LLC	67457-893	67457-893-08	8 VIAL, SINGLE-DOSE in 1 CARTON (67457-893-08) / 10 mL in 1 VIAL, SINGLE-DOSE (67457-893-00)

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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.