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Serving leading biopharmaceutical companies globally:

Novartis
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QuintilesIMS
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Generated: December 16, 2017

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 six 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. Eleven suppliers are listed for this compound. Additional details are available on the esmolol hydrochloride profile page.

Summary for 076573

Tradename:1
Applicant:1
Ingredient:1
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 63323-652-10 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-652-10) > 10 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 001

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


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Serving leading biopharmaceutical companies globally:

Moodys
McKinsey
Federal Trade Commission
Covington
Harvard Business School
Queensland Health
UBS
Accenture
Fish and Richardson
Novartis

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