Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Express Scripts
Healthtrust
Harvard Business School
Medtronic
Moodys
Accenture
Argus Health
AstraZeneca

Generated: May 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202259

« Back to Dashboard

NDA 202259 describes BUSULFAN, which is a drug marketed by Actavis Llc, Amneal Pharms Co, Luitpold Pharms Inc, Pharmascience Inc, and Sandoz Inc, and is included in five 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 202259
Tradename:BUSULFAN
Applicant:Luitpold Pharms Inc
Ingredient:busulfan
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 N 0517-0920-08

Profile for product number 001

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

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

US Army
Johnson and Johnson
Cantor Fitzgerald
Cerilliant
Boehringer Ingelheim
Chinese Patent Office
Dow
UBS
Healthtrust

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.