FDA.reportPublic FDA data

Application 076575

Type
ANDA
Sponsor
TEVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TOPIRAMATETOPIRAMATECAPSULE;ORAL15MGNoNo
002TOPIRAMATETOPIRAMATECAPSULE;ORAL25MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-7335TopiramateTopiramateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7335TopiramateTopiramateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7335TopiramateTopiramateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7335TopiramateTopiramateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7335TopiramateTopiramateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7336TopiramateTopiramateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7336TopiramateTopiramateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7336TopiramateTopiramateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7336TopiramateTopiramateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7336TopiramateTopiramateTeva Pharmaceuticals USA, Inc.ANDACurrent
53808-0932TopiramateTOPIRAMATEState of Florida DOH Central PharmacyANDACurrent
63629-6871TopiramateTopiramateBryant Ranch PrepackANDACurrent
63629-6871TopiramateTopiramateBryant Ranch PrepackANDACurrent
63629-6871TopiramateTopiramateBryant Ranch PrepackANDACurrent