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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 210576


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NDA 210576 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, Nexus, Norvium Bioscience, Penn Life, Somerset Theraps Llc, Zydus Pharms, Armour Pharm, DEY, and Parke Davis, and is included in twenty-seven 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 210576
Tradename:ISOPROTERENOL HYDROCHLORIDE
Applicant:Amneal
Ingredient:isoproterenol hydrochloride
Patents:0
Pharmacology for NDA: 210576
Mechanism of ActionAdrenergic beta-Agonists
Suppliers and Packaging for NDA: 210576
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ISOPROTERENOL HYDROCHLORIDE isoproterenol hydrochloride INJECTABLE;INJECTION 210576 ANDA Amneal Pharmaceuticals LLC 70121-1604 70121-1604-7 10 VIAL in 1 CARTON (70121-1604-7) / 1 mL in 1 VIAL (70121-1604-1)
ISOPROTERENOL HYDROCHLORIDE isoproterenol hydrochloride INJECTABLE;INJECTION 210576 ANDA Amneal Pharmaceuticals LLC 70121-1605 70121-1605-7 10 VIAL in 1 CARTON (70121-1605-7) / 5 mL in 1 VIAL (70121-1605-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.2MG/ML
Approval Date:Oct 17, 2018TE:APRLD:No

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