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FDA Approval

Levalbuterol

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
January 31, 2019
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Levosalbutamol(1.25 mg in 3 mL)

Products3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Levalbuterol

Product Details

NDC Product Code
0093-4148
Application Number
ANDA090297
Marketing Category
ANDA (C73584)
Route of Administration
RESPIRATORY (INHALATION)
Effective Date
January 31, 2019
SULFURIC ACIDInactive
Code: O40UQP6WCFClass: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95KClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
Code: WDQ1526QJMClass: ACTIMQuantity: 1.25 mg in 3 mL
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT

Levalbuterol

Product Details

NDC Product Code
0093-4145
Application Number
ANDA090297
Marketing Category
ANDA (C73584)
Route of Administration
RESPIRATORY (INHALATION)
Effective Date
January 31, 2019
Code: WDQ1526QJMClass: ACTIMQuantity: 0.31 mg in 3 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95KClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCFClass: IACT

Levalbuterol

Product Details

NDC Product Code
0093-4146
Application Number
ANDA090297
Marketing Category
ANDA (C73584)
Route of Administration
RESPIRATORY (INHALATION)
Effective Date
January 31, 2019
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
Code: WDQ1526QJMClass: ACTIMQuantity: 0.63 mg in 3 mL
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95KClass: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCFClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
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