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Last Updated: June 20, 2024

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. There is one patent 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:Hikma
Ingredient:levalbuterol hydrochloride
Patents:0

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;INHALATIONStrengthEQ 0.021% BASE
Approval Date:Mar 25, 1999TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;INHALATIONStrengthEQ 0.042% BASE
Approval Date:Mar 25, 1999TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;INHALATIONStrengthEQ 0.0103% BASE
Approval Date:Jan 30, 2002TE:RLD:Yes

Expired US Patents for NDA 020837

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Hikma XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-003 Jan 30, 2002 ⤷  Sign Up ⤷  Sign Up
Hikma XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-004 Jul 18, 2003 ⤷  Sign Up ⤷  Sign Up
Hikma XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-004 Jul 18, 2003 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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