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Generated: April 19, 2019

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Details for New Drug Application (NDA): 202259

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NDA 202259 describes BUSULFAN, which is a drug marketed by Accord Hlthcare Inc, Actavis Llc, Amneal Pharms Co, Athenex Inc, Hospira Inc, Luitpold, Mylan Labs Ltd, Nexus Pharms, and Pharmascience Inc, and is included in nine NDAs. It is available from seven 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. Ten suppliers are listed for this compound. Additional details are available on the busulfan profile page.
Summary for 202259
Formulation / Manufacturing:see details
Pharmacology for NDA: 202259
Mechanism of ActionAlkylating Activity
Suppliers and Packaging for NDA: 202259
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUSULFAN busulfan INJECTABLE;INJECTION 202259 ANDA American Regent, Inc. 0517-0920 0517-0920-08 8 VIAL in 1 PACKAGE (0517-0920-08) > 10 mL in 1 VIAL (0517-0920-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength6MG/ML
Approval Date:Dec 22, 2015TE:APRLD:No

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