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Last Updated: September 26, 2022

Details for New Drug Application (NDA): 207050


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NDA 207050 describes BUSULFAN, which is a drug marketed by Accord Hlthcare Inc, Actavis Llc, Am Regent, Amneal, Apotex, Arthur Grp, Hospira Inc, Meitheal, Mylan Institutional, Mylan Labs Ltd, Nexus Pharms, Pharmascience Inc, and Shilpa, and is included in thirteen NDAs. It is available from nine 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. Eleven suppliers are listed for this compound. Additional details are available on the busulfan profile page.
Summary for 207050
Tradename:BUSULFAN
Applicant:Pharmascience Inc
Ingredient:busulfan
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 207050
Mechanism of ActionAlkylating Activity
Suppliers and Packaging for NDA: 207050
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUSULFAN busulfan INJECTABLE;INJECTION 207050 ANDA Sagent Pharmaceuticals 25021-241 25021-241-10 8 VIAL in 1 CARTON (25021-241-10) > 10 mL in 1 VIAL
BUSULFAN busulfan INJECTABLE;INJECTION 207050 ANDA Pharmascience Inc. 51817-170 51817-170-01 8 VIAL in 1 PACKAGE (51817-170-01) > 10 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength6MG/ML
Approval Date:Mar 24, 2017TE:APRLD:No

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