Application 202961

Type
ANDA
Sponsor
AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXCARBAZEPINEOXCARBAZEPINESUSPENSION;ORAL300MG/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50268-649OxcarbazepineOxcarbazepineAvPAKANDACurrent
50268-649OxcarbazepineOxcarbazepineAvPAKANDACurrent
50268-649OxcarbazepineOxcarbazepineAvPAKANDACurrent
65162-649OxcarbazepineOxcarbazepineAmneal Pharmaceuticals LLCANDACurrent
65162-649OxcarbazepineOxcarbazepineAmneal Pharmaceuticals LLCANDACurrent
65162-649OxcarbazepineOxcarbazepineAmneal Pharmaceuticals LLCANDACurrent
68094-123OxcarbazepineOxcarbazepinePrecision Dose, Inc.ANDACurrent
70518-2946OxcarbazepineOxcarbazepineREMEDYREPACK INC.ANDACurrent