Details for New Drug Application (NDA): 205520

NDA 205520 describes ESMOLOL HYDROCHLORIDE, which is a drug marketed by Am Regent, Amneal, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hq Spclt Pharma, Mylan Institutional, Mylan Labs Ltd, and Sagent Pharms Inc, and is included in twelve NDAs. It is available from ten suppliers. There are two 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

Tradename:	ESMOLOL HYDROCHLORIDE
Applicant:	Eugia Pharma
Ingredient:	esmolol hydrochloride
Patents:	0

Pharmacology for NDA: 205520

Mechanism of Action

Adrenergic 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	Henry Schein, Inc.	0404-9858	0404-9858-10	1 VIAL, SINGLE-DOSE in 1 BAG (0404-9858-10) / 10 mL in 1 VIAL, SINGLE-DOSE
ESMOLOL HYDROCHLORIDE	esmolol hydrochloride	INJECTABLE;INJECTION	205520	ANDA	HF Acquisition Co LLC, DBA HealthFirst	51662-1444	51662-1444-1	10 mL in 1 VIAL, SINGLE-DOSE (51662-1444-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	10MG/ML
Approval Date:	Jul 23, 2015	TE:	AP	RLD:	No

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