FDA.reportPublic FDA data

Application 088254

Type
ANDA
Sponsor
WOCKHARDT BIO AG

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXAMETHASONEDEXAMETHASONEELIXIR;ORAL0.5MG/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60432-466DexamethasoneDexamethasoneMorton Grove Pharmaceuticals, Inc.ANDACurrent
64679-810BaycadronDexamethasoneWockhardt USA, LLCANDACurrent