FDA.reportPublic FDA data

Application 077636

Type
ANDA
Sponsor
CELLTRION

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
33261-843ZONISAMIDEZONISAMIDEAidarex Pharmaceuticals LLCANDACurrent
55648-945ZONISAMIDEZONISAMIDEWOCKHARDT LIMITEDANDACurrent
55648-946ZONISAMIDEZONISAMIDEWOCKHARDT LIMITEDANDACurrent
55648-990ZONISAMIDEZONISAMIDEWOCKHARDT LIMITEDANDACurrent
61919-749ZONISAMIDEZONISAMIDEDIRECT RXANDACurrent
61919-749ZONISAMIDEZONISAMIDEDIRECT RXANDACurrent
63629-5008ZONISAMIDEZONISAMIDEBryant Ranch PrepackANDACurrent
64679-945ZONISAMIDEZONISAMIDEWockhardt USA LLC.ANDACurrent
64679-946ZONISAMIDEZONISAMIDEWockhardt USA LLC.ANDACurrent
64679-990ZONISAMIDEZONISAMIDEWockhardt USA LLC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
24160ORIG2008-02-01
31268ORIG2005-12-28