FDA.reportPublic FDA data

Application 215059

Type
ANDA
Sponsor
GLAND PHARMA LTD

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68083-462Arsenic TrioxideArsenic TrioxideGland Pharma LimitedANDACurrent
68083-462Arsenic TrioxideArsenic TrioxideGland Pharma LimitedANDACurrent
68083-535Arsenic TrioxideArsenic TrioxideGland Pharma LimitedANDACurrent