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

Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Baxter
Julphar
Fish and Richardson
Harvard Business School
US Army
Cerilliant
Daiichi Sankyo
Healthtrust

Generated: July 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200752

« Back to Dashboard

NDA 200752 describes DEXRAZOXANE HYDROCHLORIDE, which is a drug marketed by Gland Pharma Ltd, Mylan Institutional, and West-ward Pharms Int, and is included in three NDAs. It is available from five suppliers. Additional details are available on the DEXRAZOXANE HYDROCHLORIDE profile page.

The generic ingredient in DEXRAZOXANE HYDROCHLORIDE is dexrazoxane hydrochloride. There are six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the dexrazoxane hydrochloride profile page.
Summary for 200752
Tradename:DEXRAZOXANE HYDROCHLORIDE
Applicant:Mylan Institutional
Ingredient:dexrazoxane hydrochloride
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 200752
Suppliers and Packaging for NDA: 200752
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXRAZOXANE HYDROCHLORIDE dexrazoxane hydrochloride INJECTABLE;INJECTION 200752 ANDA Mylan Institutional LLC 67457-207 N 67457-207-25
DEXRAZOXANE HYDROCHLORIDE dexrazoxane hydrochloride INJECTABLE;INJECTION 200752 ANDA Mylan Institutional LLC 67457-208 N 67457-208-50

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 250MG BASE/VIAL
Approval Date:Oct 19, 2011TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:Oct 19, 2011TE: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:

Healthtrust
Covington
US Army
Mallinckrodt
Cerilliant
Farmers Insurance
Cipla
Citi
Harvard Business School

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.