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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 020837

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NDA 020837 describes XOPENEX, which is a drug marketed by Hikma and Lupin and is included in two NDAs. Additional details are available on the XOPENEX profile page.

The generic ingredient in XOPENEX is levalbuterol tartrate. There are nine drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the levalbuterol tartrate profile page.

Summary for 020837

Tradename:	XOPENEX
Applicant:	Hikma
Ingredient:	levalbuterol hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INHALATION			Strength	EQ 0.021% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Mar 25, 1999	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INHALATION			Strength	EQ 0.042% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Mar 25, 1999	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INHALATION			Strength	EQ 0.0103% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jan 30, 2002	TE:		RLD:	Yes

Expired US Patents for NDA 020837

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Hikma	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-002	Mar 25, 1999	6,451,289	⤷ Get Started Free
Hikma	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-002	Mar 25, 1999	5,844,002	⤷ Get Started Free
Hikma	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-001	Mar 25, 1999	5,362,555	⤷ Get Started Free
Hikma	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-004	Jul 18, 2003	5,547,994	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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