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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 076323

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NDA 076323 describes ESMOLOL HYDROCHLORIDE, which is a drug marketed by Am Regent, Amneal, Eugia Pharma, Fresenius Kabi Usa, Gland, Hikma, Hq Spclt Pharma, Mylan Institutional, Mylan Labs Ltd, and Sagent Pharms Inc, and is included in twelve NDAs. It is available from twelve 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. Fourteen suppliers are listed for this compound. Additional details are available on the esmolol hydrochloride profile page.

Summary for 076323

Tradename:	ESMOLOL HYDROCHLORIDE
Applicant:	Hikma
Ingredient:	esmolol hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	10MG/ML
Approval Date:	Aug 10, 2004	TE:	AP	RLD:	No

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