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Generated: August 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202259

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NDA 202259 describes BUSULFAN, which is a drug marketed by Sandoz Inc, Pharmascience Inc, and Luitpold Pharms Inc, and is included in three NDAs. It is available from three 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. Five suppliers are listed for this compound. Additional details are available on the busulfan profile page.

Summary for NDA: 202259

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 202259

Mechanism of ActionAlkylating Activity

Suppliers and Packaging for NDA: 202259

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUSULFAN
busulfan
INJECTABLE;INJECTION 202259 ANDA American Regent, Inc. 0517-0920 0517-0920-08 8 VIAL in 1 PACKAGE (0517-0920-08) > 10 mL in 1 VIAL (0517-0920-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength6MG/ML
Approval Date:Dec 22, 2015TE:APRLD:No


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Serving 500+ biopharmaceutical companies globally:

Cantor Fitzgerald
Mallinckrodt
Medtronic
Johnson and Johnson
Healthtrust
Farmers Insurance
Moodys
Merck
Express Scripts
Chinese Patent Office

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