FDA.reportPublic FDA data

Application 201966

Type
ANDA
Sponsor
SANDOZ INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUDESONIDEBUDESONIDESUSPENSION;INHALATION1MG/2MLNoNo
002BUDESONIDEBUDESONIDESUSPENSION;INHALATION0.5MG/2MLNoNo
003BUDESONIDEBUDESONIDESUSPENSION;INHALATION0.25MG/2MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-7515BudesonideBudesonideSandoz IncANDACurrent
0781-7515BudesonideBudesonideSandoz IncANDACurrent
0781-7515BudesonideBudesonideSandoz IncANDACurrent
0781-7516BudesonideBudesonideSandoz IncANDACurrent
0781-7516BudesonideBudesonideSandoz IncANDACurrent
0781-7516BudesonideBudesonideSandoz IncANDACurrent
0781-7517BudesonideBudesonideSandoz IncANDACurrent
0781-7517BudesonideBudesonideSandoz IncANDACurrent
0781-7517BudesonideBudesonideSandoz IncANDACurrent
68788-6796BudesonideBudesonidePreferred Pharmaceuticals Inc.ANDACurrent
68788-6796BudesonideBudesonidePreferred Pharmaceuticals Inc.ANDACurrent
68788-7020BudesonideBudesonidePreferred Pharmaceuticals Inc.ANDACurrent
68788-7020BudesonideBudesonidePreferred Pharmaceuticals Inc.ANDACurrent