Application 216066

Type
ANDA
Sponsor
ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ERYTHROMYCINERYTHROMYCINTABLET;ORAL250MGNoNo
002ERYTHROMYCINERYTHROMYCINTABLET;ORAL500MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
67877-762ERYTHROMYCINERYTHROMYCINAscend Laboratories, LLCANDACurrent
67877-763ERYTHROMYCINERYTHROMYCINAscend Laboratories, LLCANDACurrent