FDA.reportPublic FDA data

Application 203468

Type
ANDA
Sponsor
PRINSTON 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
43547-345LEVETIRACETAMLEVETIRACETAMSolco Healthcare US, LLCANDACurrent
43547-345LEVETIRACETAMLEVETIRACETAMSolco Healthcare US, LLCANDACurrent
43547-345LEVETIRACETAMLEVETIRACETAMSolco healthcare U.S., LLCANDACurrent
43547-345LEVETIRACETAMLEVETIRACETAMSolco healthcare U.S., LLCANDACurrent
43547-345LEVETIRACETAMLEVETIRACETAMSolco Healthcare US, LLCANDACurrent
43547-346LEVETIRACETAMLEVETIRACETAMSolco Healthcare US, LLCANDACurrent
43547-346LEVETIRACETAMLEVETIRACETAMSolco Healthcare US, LLCANDACurrent
43547-346LEVETIRACETAMLEVETIRACETAMSolco healthcare U.S., LLCANDACurrent
43547-346LEVETIRACETAMLEVETIRACETAMSolco healthcare U.S., LLCANDACurrent
43547-346LEVETIRACETAMLEVETIRACETAMSolco Healthcare US, LLCANDACurrent