FDA.reportPublic FDA data

Application 201464

Type
ANDA
Sponsor
PHARMADAX INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVETIRACETAMLEVETIRACETAMTABLET, EXTENDED RELEASE;ORAL500MGNoNo
002LEVETIRACETAMLEVETIRACETAMTABLET, EXTENDED RELEASE;ORAL750MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
52817-110levetiracetamlevetiracetamTrupharma, LLCANDACurrent
52817-110levetiracetamlevetiracetamTrupharma, LLCANDACurrent
52817-111levetiracetamlevetiracetamTrupharma, LLCANDACurrent
52817-111levetiracetamlevetiracetamTrupharma, LLCANDACurrent
64376-697LevetiracetamLevetiracetamPar PharmaceuticalANDACurrent
75834-245LEVETIRACETAM EXTENDED RELEASELEVETIRACETAMNivagen Pharmaceuticals, Inc.ANDACurrent
75834-246LEVETIRACETAM EXTENDED RELEASELEVETIRACETAMNivagen Pharmaceuticals, Inc.ANDACurrent