FDA.reportPublic FDA data

Application 210948

Type
ANDA
Sponsor
ARISE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALBUTEROL SULFATEALBUTEROL SULFATETABLET;ORALEQ 2MG BASENoNo
002ALBUTEROL SULFATEALBUTEROL SULFATETABLET;ORALEQ 4MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69339-126Albuterolalbuterol sulfateDash Pharmaceutical LLCANDACurrent
69339-126Albuterolalbuterol sulfateDash Pharmaceutical LLCANDACurrent
69339-127Albuterolalbuterol sulfateDash Pharmaceutical LLCANDACurrent
69339-127Albuterolalbuterol sulfateDash Pharmaceutical LLCANDACurrent
75834-273Albuterolalbuterol sulfateNivagen Pharmaceuticals IncANDACurrent
75834-273Albuterolalbuterol sulfateNivagen Pharmaceuticals IncANDACurrent
75834-274Albuterolalbuterol sulfateNivagen Pharmaceuticals IncANDACurrent
75834-274Albuterolalbuterol sulfateNivagen Pharmaceuticals IncANDACurrent