FDA.reportPublic FDA data

Application 202284

Type
ANDA
Sponsor
ANI PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FELBAMATEFELBAMATETABLET;ORAL400MGNoNo
002FELBAMATEFELBAMATETABLET;ORAL600MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0115-1746FelbamateFelbamateImpax GenericsANDACurrent
0115-1747FelbamateFelbamateImpax GenericsANDACurrent
62559-730FelbamateFelbamateANI Pharmaceuticals, Inc.ANDACurrent
62559-730FelbamateFelbamateANI Pharmaceuticals, Inc.ANDACurrent
62559-730FelbamateFelbamateANI Pharmaceuticals, Inc.ANDACurrent
62559-731FelbamateFelbamateANI Pharmaceuticals, Inc.ANDACurrent
62559-731FelbamateFelbamateANI Pharmaceuticals, Inc.ANDACurrent
62559-731FelbamateFelbamateANI Pharmaceuticals, Inc.ANDACurrent
63629-1937FelbamateFelbamateBryant Ranch PrepackANDACurrent
63629-1937FelbamateFelbamateBryant Ranch PrepackANDACurrent
63629-1944FelbamateFelbamateBryant Ranch PrepackANDACurrent
63629-1944FelbamateFelbamateBryant Ranch PrepackANDACurrent
64720-256FelbamateFelbamateCorePharma, LLCANDACurrent