FDA.reportPublic FDA data

Application 202095

Type
ANDA
Sponsor
LOTUS PHARM CO LTD

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
40051-079LEVETIRACETAM Extended-releaselevetiracetamLotus Pharmaceutical Co., Ltd. Nantou PlantANDACurrent
40051-332LEVETIRACETAM Extended-releaselevetiracetamLotus Pharmaceutical Co., Ltd. Nantou PlantANDACurrent
69102-200ROWEEPRA XRlevetiracetamOWP Pharmaceuticals, Inc.ANDACurrent
69102-201ROWEEPRA XRlevetiracetamOWP Pharmaceuticals, Inc.ANDACurrent