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

Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Daiichi Sankyo

Generated: May 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205520

« Back to Dashboard

NDA 205520 describes ESMOLOL HYDROCHLORIDE, which is a drug marketed by Aurobindo Pharma Ltd, Fresenius Kabi Usa, Luitpold Pharms Inc, Mylan Institutional, West-ward Pharms Int, and Hq Spclt Pharma, and is included in six NDAs. It is available from seven suppliers. There are four patents protecting this drug. Additional details are available on the ESMOLOL HYDROCHLORIDE profile page.

The generic ingredient in ESMOLOL HYDROCHLORIDE is esmolol hydrochloride. There are eight drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the esmolol hydrochloride profile page.
Summary for 205520
Applicant:Aurobindo Pharma Ltd
Ingredient:esmolol hydrochloride
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 205520
Mechanism of ActionAdrenergic beta-Antagonists
Suppliers and Packaging for NDA: 205520
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESMOLOL HYDROCHLORIDE esmolol hydrochloride INJECTABLE;INJECTION 205520 ANDA AuroMedics Pharma LLC 55150-194 N 55150-194-10
ESMOLOL HYDROCHLORIDE esmolol hydrochloride INJECTABLE;INJECTION 205520 ANDA Medical Purchasing Solutions, LLC 71872-7049 N 71872-7049-1

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10MG/ML
Approval Date:Jul 23, 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:

Federal Trade Commission
Farmers Insurance
Fish and Richardson

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.