Details for New Drug Application (NDA): 020837

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NDA 020837 describes XOPENEX, which is a drug marketed by Akorn and Lupin and is included in two NDAs. It is available from one supplier. There are two patents protecting this drug and three Paragraph IV challenges. 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. Four suppliers are listed for this compound. Additional details are available on the levalbuterol tartrate profile page.

Summary for 020837

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

Pharmacology for NDA: 020837

Mechanism of Action	Adrenergic beta2-Agonists

Suppliers and Packaging for NDA: 020837

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837	NDA	Akorn	17478-171	17478-171-30	30 POUCH in 1 CARTON (17478-171-30) / 1 VIAL, SINGLE-DOSE in 1 POUCH (17478-171-01) / .5 mL in 1 VIAL, SINGLE-DOSE
XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837	NDA	Akorn	17478-172	17478-172-24	2 POUCH in 1 CARTON (17478-172-24) / 12 VIAL, SINGLE-DOSE in 1 POUCH (17478-172-12) / 3 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INHALATION			Strength	EQ 0.021% BASE
Approval Date:	Mar 25, 1999	TE:	AN	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INHALATION			Strength	EQ 0.042% BASE
Approval Date:	Mar 25, 1999	TE:	AN	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INHALATION			Strength	EQ 0.0103% BASE
Approval Date:	Jan 30, 2002	TE:	AN	RLD:	Yes

Expired US Patents for NDA 020837

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Akorn	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-001	Mar 25, 1999	⤷ Try a Trial	⤷ Try a Trial
Akorn	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-002	Mar 25, 1999	⤷ Try a Trial	⤷ Try a Trial
Akorn	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-001	Mar 25, 1999	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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