FDA.reportPublic FDA data

Application 216375

Type
ANDA
Sponsor
ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVETIRACETAMLEVETIRACETAMTABLET;ORAL250MGNoNo
002LEVETIRACETAMLEVETIRACETAMTABLET;ORAL500MGNoNo
003LEVETIRACETAMLEVETIRACETAMTABLET;ORAL750MGNoNo
004LEVETIRACETAMLEVETIRACETAMTABLET;ORAL1GMNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
67877-768LevetiracetamLevetiracetamAscend Laboratories, LLCANDACurrent
67877-768LevetiracetamLevetiracetamAscend Laboratories, LLCANDACurrent
67877-769LevetiracetamLevetiracetamAscend Laboratories, LLCANDACurrent
67877-769LevetiracetamLevetiracetamAscend Laboratories, LLCANDACurrent
67877-770LevetiracetamLevetiracetamAscend Laboratories, LLCANDACurrent
67877-770LevetiracetamLevetiracetamAscend Laboratories, LLCANDACurrent
67877-771LevetiracetamLevetiracetamAscend Laboratories, LLCANDACurrent
67877-771LevetiracetamLevetiracetamAscend Laboratories, LLCANDACurrent