Manufacturing Establishments (1)
Sun Pharmaceutical Medicare Limited
Sun Pharmaceutical Industries, Inc.
725420835
Products (3)
Levalbuterol Inhalation Solution
47335-753
ANDA207820
ANDA (C73584)
RESPIRATORY (INHALATION)
April 30, 2020
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
LevosalbutamolActive
Code: WDQ1526QJMClass: ACTIMQuantity: 1.25 mg in 3 mL
SULFURIC ACIDInactive
Code: O40UQP6WCFClass: IACT
NITROGENInactive
Code: N762921K75Class: IACT
Levalbuterol Inhalation Solution
47335-743
ANDA207820
ANDA (C73584)
RESPIRATORY (INHALATION)
April 30, 2020
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
LevosalbutamolActive
Code: WDQ1526QJMClass: ACTIMQuantity: 0.31 mg in 3 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
NITROGENInactive
Code: N762921K75Class: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCFClass: IACT
Levalbuterol Inhalation Solution
47335-746
ANDA207820
ANDA (C73584)
RESPIRATORY (INHALATION)
April 30, 2020
LevosalbutamolActive
Code: WDQ1526QJMClass: ACTIMQuantity: 0.63 mg in 3 mL
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
NITROGENInactive
Code: N762921K75Class: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCFClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT