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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 087025

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NDA 087025 describes ISOETHARINE HYDROCHLORIDE, which is a drug marketed by Alpharma Us Pharms, Astrazeneca, Baxter Hlthcare, DEY, Intl Medication, Parke Davis, and Roxane, and is included in thirty-three NDAs. Additional details are available on the ISOETHARINE HYDROCHLORIDE profile page.

The generic ingredient in ISOETHARINE HYDROCHLORIDE is isoetharine hydrochloride. There are four drug master file entries for this compound. Additional details are available on the isoetharine hydrochloride profile page.

Summary for 087025

Tradename:	ISOETHARINE HYDROCHLORIDE
Applicant:	Roxane
Ingredient:	isoetharine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INHALATION			Strength	0.125%
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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