Albuterol Sulfate
Approved
Approval ID
9e6e982b-7dfe-45b8-aa76-754e8d2a8ef6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 1, 2022
Manufacturers
FDA
Mylan Pharmaceuticals Inc.
DUNS: 059295980
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Albuterol Sulfate
PRODUCT DETAILS
NDC Product Code0378-7057
Application NumberANDA214531
Marketing CategoryC73584
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateApril 15, 2022
Generic NameAlbuterol Sulfate
INGREDIENTS (4)
ALBUTEROL SULFATEActive
Quantity: 0.63 mg in 3 mL
Code: 021SEF3731
Classification: ACTIM
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
Albuterol Sulfate
PRODUCT DETAILS
NDC Product Code0378-7058
Application NumberANDA214531
Marketing CategoryC73584
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateApril 15, 2022
Generic NameAlbuterol Sulfate
INGREDIENTS (4)
ALBUTEROL SULFATEActive
Quantity: 1.25 mg in 3 mL
Code: 021SEF3731
Classification: ACTIM
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT