Application 215249

Type
ANDA
Sponsor
RUBICON

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PREGABALINPREGABALINTABLET, EXTENDED RELEASE;ORAL82.5MGNoNo
002PREGABALINPREGABALINTABLET, EXTENDED RELEASE;ORAL165MGNoNo
003PREGABALINPREGABALINTABLET, EXTENDED RELEASE;ORAL330MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
72888-049PregabalinPregabalinAdvagen Pharma Ltd.ANDACurrent
72888-050PregabalinPregabalinAdvagen Pharma Ltd.ANDACurrent
72888-051PregabalinPregabalinAdvagen Pharma Ltd.ANDACurrent