FDA.reportPublic FDA data

Application 204511

Type
ANDA
Sponsor
ANDA REPOSITORY

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
35208-031LevetiracetamLevetiracetamIntelliPharmaCeutics Corp.ANDACurrent
35208-032LevetiracetamLevetiracetamIntelliPharmaCeutics Corp.ANDACurrent