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Last Updated: July 13, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208536


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NDA 208536 describes BUSULFAN, which is a drug marketed by Accord Hlthcare Inc, Actavis Llc, Amneal, Apotex, Athenex Inc, Hospira Inc, Luitpold, Mylan Institutional, Mylan Labs Ltd, Nexus Pharms, Pharmascience Inc, and Shilpa Medicare Ltd, and is included in twelve NDAs. It is available from eleven 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. Twelve 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 208536
Mechanism of ActionAlkylating Activity
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:RXDosage:INJECTABLE;INJECTIONStrength6MG/ML
Approval Date:Nov 20, 2017TE:APRLD:No

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