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Last Updated: June 4, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 210931


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NDA 210931 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 210931
Tradename:BUSULFAN
Applicant:Shilpa Medicare Ltd
Ingredient:busulfan
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 210931
Mechanism of ActionAlkylating Activity
Suppliers and Packaging for NDA: 210931
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUSULFAN busulfan INJECTABLE;INJECTION 210931 ANDA Fresenius Kabi USA, LLC 65219-160 65219-160-10 8 CARTON in 1 CARTON (65219-160-10) > 1 VIAL, SINGLE-DOSE in 1 CARTON (65219-160-01) > 10 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength6MG/ML
Approval Date:Apr 18, 2019TE:APRLD:No

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