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Generated: December 11, 2018

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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 Actavis Llc, Amneal Pharms Co, Hospira Inc, Luitpold, Mylan Labs Ltd, Pharmascience Inc, and Sandoz Inc, and is included in seven NDAs. It is available from five 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. Eight suppliers are listed for this compound. Additional details are available on the busulfan profile page.
Summary for 202259
Tradename:BUSULFAN
Applicant:Luitpold
Ingredient:busulfan
Patents:0
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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