FDA.reportPublic FDA data

Application 209315

Type
ANDA
Sponsor
INGENUS PHARMS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ARSENIC TRIOXIDEARSENIC TRIOXIDEINJECTABLE;INJECTION1MG/MLNoNo
002ARSENIC TRIOXIDEARSENIC TRIOXIDEINJECTABLE;INJECTION2MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50742-438ARSENIC TRIOXIDEarsenic trioxideIngenus Pharmaceuticals, LLCANDACurrent
50742-438ARSENIC TRIOXIDEarsenic trioxideIngenus Pharmaceuticals, LLCANDACurrent
50742-438ARSENIC TRIOXIDEarsenic trioxideIngenus Pharmaceuticals, LLCANDACurrent
50742-438ARSENIC TRIOXIDEarsenic trioxideIngenus Pharmaceuticals, LLCANDACurrent
50742-438ARSENIC TRIOXIDEarsenic trioxideIngenus Pharmaceuticals, LLCANDACurrent
50742-525ARSENIC TRIOXIDEarsenic trioxideIngenus Pharmaceuticals, LLCANDACurrent
70860-217Arsenic Trioxidearsenic trioxideAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-217Arsenic Trioxidearsenic trioxideAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-217Arsenic Trioxidearsenic trioxideAthenex Pharmaceutical Division, LLC.ANDACurrent