FDA.reportPublic FDA data

Application 090297

Type
ANDA
Sponsor
TEVA PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVALBUTEROL HYDROCHLORIDELEVALBUTEROL HYDROCHLORIDESOLUTION;INHALATIONEQ 0.0103% BASENoNo
002LEVALBUTEROL HYDROCHLORIDELEVALBUTEROL HYDROCHLORIDESOLUTION;INHALATIONEQ 0.021% BASENoNo
003LEVALBUTEROL HYDROCHLORIDELEVALBUTEROL HYDROCHLORIDESOLUTION;INHALATIONEQ 0.042% BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-4145LevalbuterolLevalbuterolTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-4145LevalbuterolLevalbuterolTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-4146LevalbuterolLevalbuterolTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-4146LevalbuterolLevalbuterolTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-4148LevalbuterolLevalbuterolTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-4148LevalbuterolLevalbuterolTeva Pharmaceuticals USA, Inc.ANDACurrent
63187-953LevalbuterolLevalbuterolProficient Rx LPANDACurrent
63187-953LevalbuterolLevalbuterolProficient Rx LPANDACurrent
68788-6777LevalbuterolLevalbuterolPreferred Pharmaceuticals, Inc.ANDACurrent
68788-6777LevalbuterolLevalbuterolPreferred Pharmaceuticals, Inc.ANDACurrent
70518-2760LevalbuterolLevalbuterolREMEDYREPACK INC.ANDACurrent
70518-2760LevalbuterolLevalbuterolREMEDYREPACK INC.ANDACurrent