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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 206961


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NDA 206961 describes ISOPROTERENOL HYDROCHLORIDE, which is a drug marketed by 3M, Alpharma Us Pharms, Abraxis Pharm, Am Regent, Amneal, Amphastar Pharms Inc, Amring Pharms, Avet Lifesciences, Baxter Hlthcare, Cipla, Eugia Pharma, Hikma, Hospira, Intl Medication, Micro Labs, Mylan Labs Ltd, Nexus, Penn Life, Zydus Pharms, Armour Pharm, DEY, and Parke Davis, and is included in twenty-six NDAs. It is available from eleven suppliers. Additional details are available on the ISOPROTERENOL HYDROCHLORIDE profile page.

The generic ingredient in ISOPROTERENOL HYDROCHLORIDE is isoproterenol hydrochloride. There are seventeen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the isoproterenol hydrochloride profile page.
Summary for 206961
Tradename:ISOPROTERENOL HYDROCHLORIDE
Applicant:Nexus
Ingredient:isoproterenol hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 206961
Mechanism of ActionAdrenergic beta-Agonists
Suppliers and Packaging for NDA: 206961
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ISOPROTERENOL HYDROCHLORIDE isoproterenol hydrochloride INJECTABLE;INJECTION 206961 ANDA Nexus Pharmaceuticals Inc 14789-011 14789-011-01 10 VIAL, SINGLE-DOSE in 1 CARTON (14789-011-01) / 1 mL in 1 VIAL, SINGLE-DOSE
ISOPROTERENOL HYDROCHLORIDE isoproterenol hydrochloride INJECTABLE;INJECTION 206961 ANDA Nexus Pharmaceuticals Inc 14789-015 14789-015-05 10 VIAL, SINGLE-DOSE in 1 CARTON (14789-015-05) / 5 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.2MG/ML
Approval Date:Aug 2, 2017TE:APRLD:No

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