FDA.reportPublic FDA data

Application 214492

Type
ANDA
Sponsor
UNICHEM

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
29300-428ZonisamideZonisamideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-428ZonisamideZonisamideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-429ZonisamideZonisamideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-429ZonisamideZonisamideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-430ZonisamideZonisamideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-430ZonisamideZonisamideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
71205-727ZonisamideZonisamideProficient Rx LPANDACurrent