FDA.reportPublic FDA data

Application 206200

Type
ANDA
Sponsor
AMNEAL 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
0904-7166BudesonideBudesonideMajor PharmaceuticalsANDACurrent
0904-7166BudesonideBudesonideMajor PharmaceuticalsANDACurrent
63629-8294BudesonideBudesonideBryant Ranch PrepackANDACurrent
63629-8294BudesonideBudesonideBryant Ranch PrepackANDACurrent
65162-778BudesonideBudesonideAmneal Pharmaceuticals LLCANDACurrent
65162-778BudesonideBudesonideAmneal Pharmaceuticals LLCANDACurrent
65162-778BudesonideBudesonideAmneal Pharmaceuticals LLCANDACurrent
65162-778BudesonideBudesonideAmneal Pharmaceuticals LLCANDACurrent
65162-778BudesonideBudesonideAmneal Pharmaceuticals LLCANDACurrent