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Generated: January 23, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 209580

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NDA 209580 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 209580
Applicant:Amneal Pharms Co
Formulation / Manufacturing:see details
Pharmacology for NDA: 209580
Mechanism of ActionAlkylating Activity
Suppliers and Packaging for NDA: 209580
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUSULFAN busulfan INJECTABLE;INJECTION 209580 ANDA Amneal Biosciences LLC 70121-1244 70121-1244-7 8 VIAL, SINGLE-DOSE in 1 CARTON (70121-1244-7) > 10 mL in 1 VIAL, SINGLE-DOSE (70121-1244-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength6MG/ML
Approval Date:Dec 18, 2017TE:APRLD:No

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