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Details for New Drug Application (NDA): 020837

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NDA 020837 describes XOPENEX, which is a drug marketed by Oak Pharms Inc and Sunovion and is included in two NDAs. It is available from eight suppliers. There are four 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. Three suppliers are listed for this compound. Additional details are available on the levalbuterol tartrate profile page.

Summary for NDA: 020837

Tradename:
XOPENEX
Applicant:
Oak Pharms Inc
Ingredient:
levalbuterol hydrochloride
Patents:1
Therapeutic Class:Respiratory Tract Agents

Pharmacology for NDA: 020837

Mechanism of ActionAdrenergic 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, Inc. 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, Inc. 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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrengthEQ 0.021% BASE
Approval Date:Mar 25, 1999TE:ANRLD:Yes
Patent:6,451,289Patent Expiration:Mar 21, 2021Product Flag?Substance Flag?Delist Request?
Regulatory Exclusivity Expiration:Jan 22, 2018
Regulatory Exclusivity Use:REVISIONS TO THE LABELING BASED ON THE OUTCOMES OF PEDIATRIC STUDIES CONDUCTED TO ASSESS THE SAFETY AND EFFICACY OF XOPENEX IN SUBJECTS LESS THAN 6 YEARS OF AGE

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrengthEQ 0.042% BASE
Approval Date:Mar 25, 1999TE:ANRLD:Yes
Patent:6,451,289Patent Expiration:Mar 21, 2021Product Flag?Substance Flag?Delist Request?

Expired Orange Book Patents for NDA: 020837

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Oak Pharms Inc
XOPENEX
levalbuterol hydrochloride
SOLUTION;INHALATION020837-002Mar 25, 19996,083,993► subscribe
Oak Pharms Inc
XOPENEX
levalbuterol hydrochloride
SOLUTION;INHALATION020837-001Mar 25, 19995,362,555► subscribe
Oak Pharms Inc
XOPENEX
levalbuterol hydrochloride
SOLUTION;INHALATION020837-002Mar 25, 19995,362,755► subscribe
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