FDA.reportPublic FDA data

Application 206309

Type
ANDA
Sponsor
RISING

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TEMOZOLOMIDETEMOZOLOMIDECAPSULE;ORAL5MGNoNo
002TEMOZOLOMIDETEMOZOLOMIDECAPSULE;ORAL20MGNoNo
003TEMOZOLOMIDETEMOZOLOMIDECAPSULE;ORAL100MGNoNo
004TEMOZOLOMIDETEMOZOLOMIDECAPSULE;ORAL140MGNoNo
005TEMOZOLOMIDETEMOZOLOMIDECAPSULE;ORAL180MGNoNo
006TEMOZOLOMIDETEMOZOLOMIDECAPSULE;ORAL250MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16571-816TEMOZOLOMIDEtemozolomideRising Pharmaceuticals, Inc.ANDACurrent
16571-816TEMOZOLOMIDEtemozolomideRising Pharmaceuticals, Inc.ANDACurrent
16571-817TEMOZOLOMIDEtemozolomideRising Pharmaceuticals, Inc.ANDACurrent
16571-817TEMOZOLOMIDEtemozolomideRising Pharmaceuticals, Inc.ANDACurrent
16571-818TEMOZOLOMIDEtemozolomideRising Pharmaceuticals, Inc.ANDACurrent
16571-818TEMOZOLOMIDEtemozolomideRising Pharmaceuticals, Inc.ANDACurrent
16571-819TEMOZOLOMIDEtemozolomideRising Pharmaceuticals, Inc.ANDACurrent
16571-819TEMOZOLOMIDEtemozolomideRising Pharmaceuticals, Inc.ANDACurrent
16571-820TEMOZOLOMIDEtemozolomideRising Pharmaceuticals, Inc.ANDACurrent
16571-820TEMOZOLOMIDEtemozolomideRising Pharmaceuticals, Inc.ANDACurrent
16571-821TEMOZOLOMIDEtemozolomideRising Pharmaceuticals, Inc.ANDACurrent
16571-821TEMOZOLOMIDEtemozolomideRising Pharmaceuticals, Inc.ANDACurrent
64980-333TEMOZOLOMIDEtemozolomideRising Pharmaceuticals, Inc.ANDACurrent
64980-334TEMOZOLOMIDEtemozolomideRising Pharmaceuticals, Inc.ANDACurrent
64980-335TEMOZOLOMIDEtemozolomideRising Pharmaceuticals, Inc.ANDACurrent
64980-336TEMOZOLOMIDEtemozolomideRising Pharmaceuticals, Inc.ANDACurrent
64980-337TEMOZOLOMIDEtemozolomideRising Pharmaceuticals, Inc.ANDACurrent
64980-338TEMOZOLOMIDEtemozolomideRising Pharmaceuticals, Inc.ANDACurrent