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Chinese Patent Office
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Generated: May 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076573

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NDA 076573 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 076573
Tradename:ESMOLOL HYDROCHLORIDE
Applicant:Fresenius Kabi Usa
Ingredient:esmolol hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 076573
Mechanism of ActionAdrenergic beta-Antagonists
Suppliers and Packaging for NDA: 076573
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESMOLOL HYDROCHLORIDE esmolol hydrochloride INJECTABLE;INJECTION 076573 ANDA Fresenius Kabi USA, LLC 63323-652 N 63323-652-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10MG/ML
Approval Date:May 2, 2005TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Daiichi Sankyo
Healthtrust
Julphar
QuintilesIMS
Boehringer Ingelheim
Moodys
Argus Health
Teva

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