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Last Updated: November 12, 2024

Details for New Drug Application (NDA): 206608


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NDA 206608 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 206608
Tradename:ESMOLOL HYDROCHLORIDE
Applicant:Mylan Labs Ltd
Ingredient:esmolol hydrochloride
Patents:0
Pharmacology for NDA: 206608
Mechanism of ActionAdrenergic beta-Antagonists
Suppliers and Packaging for NDA: 206608
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESMOLOL HYDROCHLORIDE esmolol hydrochloride INJECTABLE;INJECTION 206608 ANDA Mylan Institutional LLC 67457-657 67457-657-25 1 BAG in 1 POUCH (67457-657-25) / 250 mL in 1 BAG
ESMOLOL HYDROCHLORIDE esmolol hydrochloride INJECTABLE;INJECTION 206608 ANDA Mylan Institutional LLC 67457-658 67457-658-10 1 BAG in 1 POUCH (67457-658-10) / 100 mL in 1 BAG

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1GM/100ML
Approval Date:Jun 8, 2018TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2GM/100ML
Approval Date:Jun 8, 2018TE:APRLD:No

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