Details for New Drug Application (NDA): 021730

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NDA 021730 describes XOPENEX HFA, which is a drug marketed by Lupin and is included in one NDA. It is available from four suppliers. There is one patent protecting this drug. Additional details are available on the XOPENEX HFA profile page.

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

Summary for 021730

Tradename:	XOPENEX HFA
Applicant:	Lupin
Ingredient:	levalbuterol tartrate
Patents:	1

Pharmacology for NDA: 021730

Mechanism of Action	Adrenergic beta2-Agonists

Suppliers and Packaging for NDA: 021730

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
XOPENEX HFA	levalbuterol tartrate	AEROSOL, METERED;INHALATION	021730	NDA AUTHORIZED GENERIC	Actavis Pharma, Inc.	0591-2927	0591-2927-54	1 INHALER in 1 CARTON (0591-2927-54) / 200 AEROSOL, METERED in 1 INHALER
XOPENEX HFA	levalbuterol tartrate	AEROSOL, METERED;INHALATION	021730	NDA	Lupin Pharmaceuticals, Inc.	27437-056	27437-056-01	1 INHALER in 1 CARTON (27437-056-01) / 200 AEROSOL, METERED in 1 INHALER

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	AEROSOL, METERED;INHALATION			Strength	EQ 0.045MG BASE/INH
Approval Date:	Mar 11, 2005	TE:		RLD:	Yes
Patent:	⤷ Subscribe	Patent Expiration:	Oct 8, 2024	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patented Use:	TREATMENT OR PREVENTION OF BRONCHOSPASM OR ASTHMATIC SYMPTOMS

Expired US Patents for NDA 021730

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lupin	XOPENEX HFA	levalbuterol tartrate	AEROSOL, METERED;INHALATION	021730-001	Mar 11, 2005	⤷ Subscribe	⤷ Subscribe
Lupin	XOPENEX HFA	levalbuterol tartrate	AEROSOL, METERED;INHALATION	021730-001	Mar 11, 2005	⤷ Subscribe	⤷ Subscribe
Lupin	XOPENEX HFA	levalbuterol tartrate	AEROSOL, METERED;INHALATION	021730-001	Mar 11, 2005	⤷ Subscribe	⤷ Subscribe
Lupin	XOPENEX HFA	levalbuterol tartrate	AEROSOL, METERED;INHALATION	021730-001	Mar 11, 2005	⤷ Subscribe	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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