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Generated: January 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076474

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NDA 076474 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 076474
Applicant:Mylan Institutional
Ingredient:esmolol hydrochloride
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 076474
Mechanism of ActionAdrenergic beta-Antagonists
Suppliers and Packaging for NDA: 076474
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESMOLOL HYDROCHLORIDE esmolol hydrochloride INJECTABLE;INJECTION 076474 ANDA General Injectables and Vaccines, Inc. 52584-049 52584-049-00 1 VIAL, SINGLE-DOSE in 1 BAG (52584-049-00) > 10 mL in 1 VIAL, SINGLE-DOSE
ESMOLOL HYDROCHLORIDE esmolol hydrochloride INJECTABLE;INJECTION 076474 ANDA Mylan Institutional LLC 67457-182 67457-182-10 10 VIAL in 1 CARTON (67457-182-10) > 10 mL in 1 VIAL (67457-182-00)

Profile for product number 001

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

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