FDA.reportPublic FDA data

Application 215414

Type
ANDA
Sponsor
ASCENT PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TOPIRAMATETOPIRAMATETABLET;ORAL25MGNoNo
002TOPIRAMATETOPIRAMATETABLET;ORAL50MGNoNo
003TOPIRAMATETOPIRAMATETABLET;ORAL100MGNoNo
004TOPIRAMATETOPIRAMATETABLET;ORAL200MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
31722-181TOPIRAMATETopiramateCamber Pharmaceuticals, Inc.ANDACurrent
31722-182TOPIRAMATETopiramateCamber Pharmaceuticals, Inc.ANDACurrent
31722-183TOPIRAMATETopiramateCamber Pharmaceuticals, Inc.ANDACurrent
31722-184TOPIRAMATETopiramateCamber Pharmaceuticals, Inc.ANDACurrent
43602-457TOPIRAMATETopiramateAscent Pharmaceuticals, Inc.ANDACurrent
43602-458TOPIRAMATETopiramateAscent Pharmaceuticals, Inc.ANDACurrent
43602-459TOPIRAMATETopiramateAscent Pharmaceuticals, Inc.ANDACurrent
43602-460TOPIRAMATETopiramateAscent Pharmaceuticals, Inc.ANDACurrent