FDA.reportPublic FDA data

Application 077627

Type
ANDA
Sponsor
GLENMARK GENERICS

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
0615-8138TopiramateTopiramateNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8138TopiramateTopiramateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8138TopiramateTopiramateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8139TopiramateTopiramateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8139TopiramateTopiramateNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8139TopiramateTopiramateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8140TopiramateTopiramateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8140TopiramateTopiramateNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8140TopiramateTopiramateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
10544-489TopiramateTopiramateBlenheim Pharmacal, Inc.ANDACurrent
10544-847TopiramateTopiramateBlenheim Pharmacal, Inc.ANDACurrent
33261-106TopiramateTopiramateAidarex Pharmaceuticals LLCANDACurrent
43063-573TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-573TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-573TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-573TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-573TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-605TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-605TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-605TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-605TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-605TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-612TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-612TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-612TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-612TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-612TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
51655-032TOPIRAMATETOPIRAMATENorthwind Pharmaceuticals, LLCANDACurrent
51655-608TOPIRAMATETOPIRAMATENorthwind Pharmaceuticals, LLCANDACurrent
51655-609TopiramateTopiramateNorthwind Pharmaceuticals, LLCANDACurrent
63187-118TopiramateTopiramateProficient Rx LPANDACurrent
63187-118TopiramateTopiramateProficient Rx LPANDACurrent
63187-283TopiramateTopiramateProficient Rx LPANDACurrent
63187-283TopiramateTopiramateProficient Rx LPANDACurrent
63187-479TopiramateTopiramateProficient Rx LPANDACurrent
63187-479TopiramateTopiramateProficient Rx LPANDACurrent
68462-108TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-108TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-108TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-108TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-108TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-108TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-108TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-108TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-108TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-109TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-109TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-109TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-109TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-109TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-109TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-109TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-109TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-109TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-110TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-110TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-110TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-110TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-110TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-110TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-110TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-110TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-110TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-153TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-153TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-153TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-153TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-153TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-153TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-153TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-153TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-153TopiramateTopiramateGlenmark Pharmaceuticals Inc., USAANDACurrent
68788-6366TopiramateTopiramatePreferred PharmaceuticalcANDACurrent
68788-8967TopiramateTopiramatePreferred PharmaceuticalsANDACurrent
70518-2899TopiramateTopiramateREMEDYREPACK INC.ANDACurrent
70518-2899TopiramateTopiramateREMEDYREPACK INC.ANDACurrent
70518-2955TopiramateTopiramateREMEDYREPACK INC.ANDACurrent
70518-2955TopiramateTopiramateREMEDYREPACK INC.ANDACurrent
70518-3067TopiramateTopiramateREMEDYREPACK INC.ANDACurrent
70518-3067TopiramateTopiramateREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
23878ORIG2009-04-14