Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Generated: July 22, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205672

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NDA 205672 describes BUSULFAN, which is a drug marketed by Accord Hlthcare Inc, Actavis Llc, Amneal Pharms Co, Apotex Inc, 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 eight 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 205672
Applicant:Hospira Inc
Formulation / Manufacturing:see details
Pharmacology for NDA: 205672
Mechanism of ActionAlkylating Activity
Suppliers and Packaging for NDA: 205672
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUSULFAN busulfan INJECTABLE;INJECTION 205672 ANDA Hospira, Inc. 0409-1112 0409-1112-01 8 CARTON in 1 CARTON (0409-1112-01) > 1 VIAL, SINGLE-DOSE in 1 CARTON (0409-1112-10) > 10 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength6MG/ML
Approval Date:Jul 31, 2018TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Federal Trade Commission
US Department of Justice
Daiichi Sankyo

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