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Last Updated: December 22, 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, Gland Pharma Ltd, Hikma, Hospira, Intl Medication, Micro Labs, Nexus, Norvium Bioscience, Penn Life, Somerset Theraps Llc, Zydus Pharms, Armour Pharm, DEY, and Parke Davis, and is included in twenty-eight NDAs. It is available from twelve 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. Twelve 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
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 LLC 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 LLC 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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