FDA.reportPublic FDA data

Application 207623

Type
ANDA
Sponsor
ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PREGABALINPREGABALINSOLUTION;ORAL20MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
67877-457PregabalinPregabalinAscend Laboratories, LLCANDACurrent
67877-457PregabalinPregabalinAscend Laboratories, LLCANDACurrent
67877-457PregabalinPregabalinAscend Laboratories, LLCANDACurrent
67877-457PregabalinPregabalinAscend Laboratories, LLCANDACurrent