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Last Updated: May 29, 2020

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Details for New Drug Application (NDA): 205106

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NDA 205106 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 ten 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 205106
Applicant:Athenex Inc
Formulation / Manufacturing:see details
Pharmacology for NDA: 205106
Mechanism of ActionAlkylating Activity
Suppliers and Packaging for NDA: 205106
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUSULFAN busulfan INJECTABLE;INJECTION 205106 ANDA Athenex Pharmaceutical Division, LLC. 70860-216 70860-216-10 8 VIAL in 1 CARTON (70860-216-10) > 10 mL in 1 VIAL (70860-216-41)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength6MG/ML
Approval Date:Sep 21, 2018TE:APRLD:No

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Serving leading biopharmaceutical companies globally:

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