FDA.reportPublic FDA data

Application 078404

Type
ANDA
Sponsor
IMPAX LABS INC

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0115-1687Budesonide InhalationBudesonideImpax GenericsANDACurrent
0115-1687Budesonide InhalationBudesonideAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1687Budesonide InhalationBudesonideAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1687Budesonide InhalationBudesonideAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1687Budesonide InhalationBudesonideAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1689Budesonide InhalationBudesonideImpax GenericsANDACurrent
0115-1689Budesonide InhalationBudesonideAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1689Budesonide InhalationBudesonideAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1689Budesonide InhalationBudesonideAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1689Budesonide InhalationBudesonideAmneal Pharmaceuticals of New York LLCANDACurrent
68788-3768Budesonide InhalationBudesonidePreferred Pharmaceuticals Inc.ANDACurrent