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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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Fish and Richardson
Cantor Fitzgerald
Medtronic
McKesson
Deloitte

Generated: July 16, 2019

DrugPatentWatch Database Preview

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, 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 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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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
McKesson
UBS
McKinsey
AstraZeneca
Moodys

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