Details for New Drug Application (NDA): 215542

NDA 215542 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 215542

Tradename:	ISOPROTERENOL HYDROCHLORIDE
Applicant:	Penn Life
Ingredient:	isoproterenol hydrochloride
Patents:	0

Pharmacology for NDA: 215542

Mechanism of Action

Adrenergic beta-Agonists

Suppliers and Packaging for NDA: 215542

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ISOPROTERENOL HYDROCHLORIDE	isoproterenol hydrochloride	INJECTABLE;INJECTION	215542	ANDA	KVK-Tech, Inc.	10702-364	10702-364-51	10 VIAL in 1 CARTON (10702-364-51) / 5 mL in 1 VIAL (10702-364-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	0.2MG/ML
Approval Date:	Sep 20, 2022	TE:	AP	RLD:	No

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