FDA.reportPublic FDA data

Application 206134

Type
ANDA
Sponsor
ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUDESONIDEBUDESONIDECAPSULE;ORAL3MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-829budesonidebudesonideNorthstar Rx LLC.ANDACurrent
16714-829budesonidebudesonideNorthstar Rx LLC.ANDACurrent
16714-829budesonidebudesonideNorthstar Rx LLC.ANDACurrent
16714-829budesonidebudesonideNorthstar Rx LLC.ANDACurrent
16714-829budesonidebudesonideNorthstar Rx LLC.ANDACurrent
16714-829budesonidebudesonideNorthstar Rx LLC.ANDACurrent
60687-596BudesonideBudesonideAmerican Health PackagingANDACurrent
60687-596BudesonideBudesonideAmerican Health PackagingANDACurrent
68382-720budesonidebudesonideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-720budesonidebudesonideZydus Pharmaceuticals USA Inc.ANDACurrent
68382-720budesonidebudesonideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-720budesonidebudesonideZydus Pharmaceuticals (USANDACurrent
68382-720budesonidebudesonideZydus Pharmaceuticals (USA) Inc.ANDACurrent
70771-1075budesonidebudesonideCadila Healthcare LimitedANDACurrent
70771-1075budesonidebudesonideCadila Healthcare LimitedANDACurrent
70771-1075budesonidebudesonideCadila Healthcare LimitedANDACurrent
70771-1075budesonidebudesonideCadila Healthcare LimitedANDACurrent
70771-1075budesonidebudesonideZydus Lifesciences LimitedANDACurrent