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Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 010515

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NDA 010515 describes ISUPREL, which is a drug marketed by Sanofi Aventis Us and Hospira and is included in four NDAs. It is available from one supplier. Additional details are available on the ISUPREL profile page.

The generic ingredient in ISUPREL is isoproterenol hydrochloride. There are sixteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the isoproterenol hydrochloride profile page.
Summary for 010515
Tradename:ISUPREL
Applicant:Hospira
Ingredient:isoproterenol hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 010515
Mechanism of ActionAdrenergic beta-Agonists
Suppliers and Packaging for NDA: 010515
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ISUPREL isoproterenol hydrochloride INJECTABLE;INJECTION 010515 NDA Valeant Pharmaceuticals North America LLC 0187-4330 N 0187-4330-05
ISUPREL isoproterenol hydrochloride INJECTABLE;INJECTION 010515 NDA Valeant Pharmaceuticals North America LLC 0187-4330 N 0187-4330-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.2MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

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