FDA.reportPublic FDA data

Application 210739

Type
ANDA
Sponsor
AMNEAL EU LTD

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70121-1483Arsenic TrioxideArsenic TrioxideAmneal Pharmaceuticals LLCANDACurrent
70121-1483Arsenic TrioxideArsenic TrioxideAmneal Pharmaceuticals LLCANDACurrent
70121-1483Arsenic TrioxideArsenic TrioxideAmneal Pharmaceuticals LLCANDACurrent
70121-1658Arsenic TrioxideArsenic TrioxideAmneal Pharmaceuticals LLCANDACurrent
70121-1658Arsenic TrioxideArsenic TrioxideAmneal Pharmaceuticals LLCANDACurrent