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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 210106


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NDA 210106 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, Hikma, Hospira, Intl Medication, Micro Labs, Nexus, Penn Life, Pharmobedient, Somerset Theraps Llc, Zydus Pharms, Armour Pharm, DEY, and Parke Davis, and is included in twenty-eight NDAs. It is available from thirteen 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. Thirteen suppliers are listed for this compound. Additional details are available on the isoproterenol hydrochloride profile page.
Summary for 210106
Tradename:ISOPROTERENOL HYDROCHLORIDE
Applicant:Amphastar Pharms Inc
Ingredient:isoproterenol hydrochloride
Patents:0
Pharmacology for NDA: 210106
Mechanism of ActionAdrenergic beta-Agonists
Suppliers and Packaging for NDA: 210106
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ISOPROTERENOL HYDROCHLORIDE isoproterenol hydrochloride INJECTABLE;INJECTION 210106 ANDA Amphastar Pharmaceuticals, Inc. 0548-9501 0548-9501-00 10 VIAL in 1 CARTON (0548-9501-00) / 1 mL in 1 VIAL
ISOPROTERENOL HYDROCHLORIDE isoproterenol hydrochloride INJECTABLE;INJECTION 210106 ANDA Amphastar Pharmaceuticals, Inc. 0548-9502 0548-9502-00 10 VIAL in 1 CARTON (0548-9502-00) / 5 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.2MG/ML
Approval Date:Jun 18, 2018TE:APRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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