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Last Updated: November 18, 2019

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 Bausch 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 seventeen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the isoproterenol hydrochloride profile page.
Summary for 010515
Ingredient:isoproterenol hydrochloride
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 Bausch Health Americas, Inc. 0187-4330 0187-4330-01 25 AMPULE in 1 CARTON (0187-4330-01) > 1 mL in 1 AMPULE
ISUPREL isoproterenol hydrochloride INJECTABLE;INJECTION 010515 NDA Bausch Health Americas, Inc. 0187-4330 0187-4330-05 10 AMPULE in 1 CARTON (0187-4330-05) > 5 mL in 1 AMPULE

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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