FDA.reportPublic FDA data

Application 077625

Type
ANDA
Sponsor
ZYDUS PHARMS USA

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
68382-212ZonisamideZonisamideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-212ZonisamideZonisamideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-212ZonisamideZonisamideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-213ZonisamideZonisamideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-213ZonisamideZonisamideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-213ZonisamideZonisamideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-214ZonisamideZonisamideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-214ZonisamideZonisamideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-214ZonisamideZonisamideZydus Pharmaceuticals (USA) Inc.ANDACurrent
70771-1142ZonisamideZonisamideZydus Lifesciences LimitedANDACurrent
70771-1142ZonisamideZonisamideCadila Healthcare LimitedANDACurrent
70771-1142ZonisamideZonisamideCadila Healthcare LimitedANDACurrent
70771-1142ZonisamideZonisamideCadila Healthcare LimitedANDACurrent
70771-1143ZonisamideZonisamideCadila Healthcare LimitedANDACurrent
70771-1143ZonisamideZonisamideCadila Healthcare LimitedANDACurrent
70771-1143ZonisamideZonisamideCadila Healthcare LimitedANDACurrent
70771-1143ZonisamideZonisamideZydus Lifesciences LimitedANDACurrent
70771-1144ZonisamideZonisamideZydus Lifesciences LimitedANDACurrent
70771-1144ZonisamideZonisamideCadila Healthcare LimitedANDACurrent
70771-1144ZonisamideZonisamideCadila Healthcare LimitedANDACurrent
70771-1144ZonisamideZonisamideCadila Healthcare LimitedANDACurrent
72578-040ZonisamideZonisamideViona Pharmaceuticals IncANDACurrent
72578-040ZonisamideZonisamideViona Pharmaceuticals IncANDACurrent
72578-040ZonisamideZonisamideViona Pharmaceuticals IncANDACurrent
72578-041ZonisamideZonisamideViona Pharmaceuticals IncANDACurrent
72578-041ZonisamideZonisamideViona Pharmaceuticals IncANDACurrent
72578-041ZonisamideZonisamideViona Pharmaceuticals IncANDACurrent
72578-042ZonisamideZonisamideViona Pharmaceuticals IncANDACurrent
72578-042ZonisamideZonisamideViona Pharmaceuticals IncANDACurrent
72578-042ZonisamideZonisamideViona Pharmaceuticals IncANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44620ORIG2008-02-01