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Details for New Drug Application (NDA): 201126

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NDA 201126 describes ESMOLOL HYDROCHLORIDE, which is a drug marketed by Aurobindo Pharma Ltd, West-ward Pharms Int, Luitpold Pharms Inc, Fresenius Kabi Usa, Mylan Institutional, 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. Ten suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the esmolol hydrochloride profile page.

Summary for NDA: 201126

Tradename:
ESMOLOL HYDROCHLORIDE
Applicant:
Luitpold Pharms Inc
Ingredient:
esmolol hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 201126

Mechanism of ActionAdrenergic beta-Antagonists

Suppliers and Packaging for NDA: 201126

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESMOLOL HYDROCHLORIDE
esmolol hydrochloride
INJECTABLE;INJECTION 201126 ANDA American Regent, Inc. 0517-1810 0517-1810-10 10 VIAL, SINGLE-USE in 1 BOX (0517-1810-10) > 10 mL in 1 VIAL, SINGLE-USE (0517-1810-01)
ESMOLOL HYDROCHLORIDE
esmolol hydrochloride
INJECTABLE;INJECTION 201126 ANDA American Regent, Inc. 0517-1810 0517-1810-25 25 VIAL, SINGLE-USE in 1 TRAY (0517-1810-25) > 10 mL in 1 VIAL, SINGLE-USE (0517-1810-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10MG/ML
Approval Date:Feb 20, 2015TE:APRLD:No


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