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Serving leading biopharmaceutical companies globally:

Cerilliant
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Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205520

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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 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 205520

Tradename:1
Applicant:1
Ingredient:1
Patents:0
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 55150-194-10 25 VIAL, SINGLE-DOSE in 1 CARTON (55150-194-10) > 10 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10MG/ML
Approval Date:Jul 23, 2015TE:APRLD:No


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Serving leading biopharmaceutical companies globally:

McKesson
QuintilesIMS
Julphar
Argus Health
Boehringer Ingelheim
Cipla
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Queensland Health
Healthtrust
Chinese Patent Office

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