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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 085540

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NDA 085540 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 085540

Tradename:	ISOPROTERENOL HYDROCHLORIDE
Applicant:	Parke Davis
Ingredient:	isoproterenol hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INHALATION			Strength	0.5%
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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