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Details for New Drug Application (NDA): 021730

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NDA 021730 describes XOPENEX HFA, which is a drug marketed by Sunovion and is included in one NDA. It is available from three suppliers. There are three patents 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. Three suppliers are listed for this compound. Additional details are available on the levalbuterol tartrate profile page.

Summary for NDA: 021730

Tradename:
XOPENEX HFA
Applicant:
Sunovion
Ingredient:
levalbuterol tartrate
Patents:3

Pharmacology for NDA: 021730

Mechanism of ActionAdrenergic 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 Physicians Total Care, Inc. 54868-5689 54868-5689-0 200 AEROSOL, METERED in 1 INHALER (54868-5689-0)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, METERED;INHALATIONStrengthEQ 0.045MG BASE/INH
Approval Date:Mar 11, 2005TE:RLD:Yes
Patent:5,836,299Patent Expiration:Nov 17, 2015Product Flag?YSubstance Flag?Delist Request?
Patent:8,765,153Patent Expiration:Dec 8, 2023Product Flag?YSubstance Flag?Delist Request?
Patent:7,256,310Patent Expiration:Oct 8, 2024Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OR PREVENTION OF BRONCHOSPASM OR ASTHMATIC SYMPTOMS

Expired Orange Book Patents for NDA: 021730

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sunovion
XOPENEX HFA
levalbuterol tartrate
AEROSOL, METERED;INHALATION021730-001Mar 11, 20056,352,684► subscribe
Sunovion
XOPENEX HFA
levalbuterol tartrate
AEROSOL, METERED;INHALATION021730-001Mar 11, 20055,225,183► subscribe
Sunovion
XOPENEX HFA
levalbuterol tartrate
AEROSOL, METERED;INHALATION021730-001Mar 11, 20055,605,674► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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