Application 216486

Type
ANDA
Sponsor
AUCTA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FORMOTEROL FUMARATEFORMOTEROL FUMARATESOLUTION;INHALATION0.02MG/2MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
73289-0060Formoterol Fumarateformoterol fumarate dihydrateAucta Pharmaceuticals, IncANDACurrent
73289-0060Formoterol Fumarateformoterol fumarate dihydrateAucta Pharmaceuticals, IncANDACurrent