Application 040519

Type
ANDA
Sponsor
FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DIMENHYDRINATEDIMENHYDRINATEINJECTABLE;INJECTION50MG/MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63323-366DimenhydrinateDimenhydrinateFresenius Kabi USA, LLCANDACurrent
63323-366DimenhydrinateDimenhydrinateFresenius Kabi USA, LLCANDACurrent