Application 091360

Type
ANDA
Sponsor
ANCHEN PHARMS

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
10370-195levetiracetamlevetiracetamPar Pharmaceutical, Inc.ANDACurrent
10370-214levetiracetamlevetiracetamPar Pharmaceutical, Inc.ANDACurrent