FDA.reportPublic FDA data

Application 203067

Type
ANDA
Sponsor
ORIT LABS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVETIRACETAMLEVETIRACETAMSOLUTION;ORAL100MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
15955-327LEVETIRACETAMLEVETIRACETAMOrit Laboratories LLCANDACurrent
62332-626LEVETIRACETAMLEVETIRACETAMAlembic Pharmaceuticals Inc.ANDACurrent