FDA.reportPublic FDA data

Application 212674

Type
ANDA
Sponsor
HETERO LABS LTD V

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PIRFENIDONEPIRFENIDONETABLET;ORAL267MGNoNo
002PIRFENIDONEPIRFENIDONETABLET;ORAL801MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
31722-872PirfenidonePirfenidoneCamber Pharmaceuticals, Inc.ANDACurrent
31722-873PirfenidonePirfenidoneCamber Pharmaceuticals, Inc.ANDACurrent