MedPath
FDA Approval

Xopenex

September 14, 2022

HUMAN PRESCRIPTION DRUG LABEL

Levosalbutamol(1.25 mg in 3 mL)

Products (3)

Xopenex

17478-174

NDA020837

NDA (C73594)

RESPIRATORY (INHALATION)

June 30, 2017

Sulfuric AcidInactive
Code: O40UQP6WCFClass: IACT
NitrogenInactive
Code: N762921K75Class: IACT
Code: WDQ1526QJMClass: ACTIMQuantity: 1.25 mg in 3 mL
Sodium ChlorideInactive
Code: 451W47IQ8XClass: IACT
WaterInactive
Code: 059QF0KO0RClass: IACT

Xopenex

17478-172

NDA020837

NDA (C73594)

RESPIRATORY (INHALATION)

June 30, 2017

Code: WDQ1526QJMClass: ACTIMQuantity: 0.31 mg in 3 mL
Sodium ChlorideInactive
Code: 451W47IQ8XClass: IACT
Sulfuric AcidInactive
Code: O40UQP6WCFClass: IACT
WaterInactive
Code: 059QF0KO0RClass: IACT
NitrogenInactive
Code: N762921K75Class: IACT

Xopenex

17478-173

NDA020837

NDA (C73594)

RESPIRATORY (INHALATION)

June 30, 2017

Code: WDQ1526QJMClass: ACTIMQuantity: 0.63 mg in 3 mL
Sodium ChlorideInactive
Code: 451W47IQ8XClass: IACT
NitrogenInactive
Code: N762921K75Class: IACT
Sulfuric AcidInactive
Code: O40UQP6WCFClass: IACT
WaterInactive
Code: 059QF0KO0RClass: IACT
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