FDA.reportPublic FDA data

Application 208970

Type
ANDA
Sponsor
CADILA

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
70710-1053FelbamateFelbamateZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1053FelbamateFelbamateZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1054FelbamateFelbamateZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1054FelbamateFelbamateZydus Pharmaceuticals (USA) Inc.ANDACurrent
70771-1077FelbamateFelbamateCadila Healthcare LimitedANDACurrent
70771-1077FelbamateFelbamateZydus Lifesciences LimitedANDACurrent
70771-1077FelbamateFelbamateCadila Healthcare LimitedANDACurrent
70771-1077FelbamateFelbamateCadila Healthcare LimitedANDACurrent
70771-1078FelbamateFelbamateCadila Healthcare LimitedANDACurrent
70771-1078FelbamateFelbamateZydus Lifesciences LimitedANDACurrent
70771-1078FelbamateFelbamateCadila Healthcare LimitedANDACurrent
70771-1078FelbamateFelbamateCadila Healthcare LimitedANDACurrent
72578-056FelbamateFelbamateViona Pharmaceuticals IncANDACurrent
72578-056FelbamateFelbamateViona Pharmaceuticals IncANDACurrent
72578-057FelbamateFelbamateViona Pharmaceuticals IncANDACurrent
72578-057FelbamateFelbamateViona Pharmaceuticals IncANDACurrent