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Last Updated: February 26, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205139


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NDA 205139 describes BUSULFAN, which is a drug marketed by Accord Hlthcare Inc, Actavis Llc, Amneal, Apotex, Athenex Inc, Hospira Inc, Luitpold, Mylan Labs Ltd, Nexus Pharms, Pharmascience Inc, and Shilpa Medicare Ltd, and is included in eleven NDAs. It is available from twelve 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. Fifteen suppliers are listed for this compound. Additional details are available on the busulfan profile page.
Summary for 205139
Tradename:BUSULFAN
Applicant:Actavis Llc
Ingredient:busulfan
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 205139
Mechanism of ActionAlkylating Activity
Suppliers and Packaging for NDA: 205139
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUSULFAN busulfan INJECTABLE;INJECTION 205139 ANDA Actavis Pharma, Inc. 45963-640 45963-640-57 1 VIAL, SINGLE-DOSE in 1 CARTON (45963-640-57) > 10 mL in 1 VIAL, SINGLE-DOSE
BUSULFAN busulfan INJECTABLE;INJECTION 205139 ANDA Actavis Pharma, Inc. 45963-640 45963-640-77 8 VIAL, SINGLE-DOSE in 1 CARTON (45963-640-77) > 10 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength6MG/ML
Approval Date:Dec 8, 2017TE:APRLD:No

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