FDA.reportPublic FDA data

Application 077651

Type
ANDA
Sponsor
GLENMARK GENERICS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZONISAMIDEZONISAMIDECAPSULE;ORAL25MGNoNo
002ZONISAMIDEZONISAMIDECAPSULE;ORAL50MGNoNo
003ZONISAMIDEZONISAMIDECAPSULE;ORAL100MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-2174ZonisamideZonisamideA-S Medication SolutionsANDACurrent
61919-591ZonisamideZonisamideDirect RxANDACurrent
61919-775ZonisamideZonisamideDirect RxANDACurrent
61919-775ZONISAMIDEZONISAMIDEDirect_RxANDACurrent
61919-775ZONISAMIDEZONISAMIDEDirect_RxANDACurrent
61919-775ZONISAMIDEZONISAMIDEDirect_RxANDACurrent
63187-583ZonisamideZonisamideProficient Rx LPANDACurrent
63187-583ZonisamideZonisamideProficient Rx LPANDACurrent
63187-583ZonisamideZonisamideProficient Rx LPANDACurrent
68001-242ZonisamideZonisamideBluePoint LaboratoriesANDACurrent
68001-242ZonisamideZonisamideBluePoint LaboratoriesANDACurrent
68001-242ZonisamideZonisamideBluePoint LaboratoriesANDACurrent
68001-243ZonisamideZonisamideBluePoint LaboratoriesANDACurrent
68001-243ZonisamideZonisamideBluePoint LaboratoriesANDACurrent
68001-243ZonisamideZonisamideBluePoint LaboratoriesANDACurrent
68001-244ZonisamideZonisamideBluePoint LaboratoriesANDACurrent
68001-244ZonisamideZonisamideBluePoint LaboratoriesANDACurrent
68001-244ZonisamideZonisamideBluePoint LaboratoriesANDACurrent
68071-4152ZonisamideZonisamideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4152ZonisamideZonisamideNuCare Pharmaceuticals,Inc.ANDACurrent
68462-128ZonisamideZonisamideGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-128ZonisamideZonisamideGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-128ZonisamideZonisamideGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-128ZonisamideZonisamideGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-128ZonisamideZonisamideGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-128ZonisamideZonisamideGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-129ZonisamideZonisamideGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-129ZonisamideZonisamideGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-129ZonisamideZonisamideGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-129ZonisamideZonisamideGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-129ZonisamideZonisamideGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-129ZonisamideZonisamideGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-130ZonisamideZonisamideGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-130ZonisamideZonisamideGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-130ZonisamideZonisamideGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-130ZonisamideZonisamideGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-130ZonisamideZonisamideGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-130ZonisamideZonisamideGlenmark Pharmaceuticals Inc., USAANDACurrent
71335-0125ZonisamideZonisamideBryant Ranch PrepackANDACurrent
71335-0125ZonisamideZonisamideBryant Ranch PrepackANDACurrent
71335-0125ZonisamideZonisamideBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44627ORIG2008-02-01