FDA.reportPublic FDA data

Application 206033

Type
ANDA
Sponsor
CHEMI SPA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DECITABINEDECITABINEINJECTABLE;INTRAVENOUS50MG/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42737-110DecitabineDecitabineChemi Pharma LLCANDACurrent
68001-422DecitabineDecitabineBluePoint LaboratoriesANDACurrent
68001-422DecitabineDecitabineBluePoint LaboratoriesANDACurrent
68001-422DecitabineDecitabineBluePoint LaboratoriesANDACurrent
68001-422DecitabineDecitabineBluePoint LaboratoriesANDACurrent
70121-1644DecitabinedecitabineAmneal Pharmaceuticals LLCANDACurrent
70121-1644DecitabinedecitabineAmneal Pharmaceuticals LLCANDACurrent
70121-1644DecitabinedecitabineAmneal Pharmaceuticals LLCANDACurrent
70121-1644DecitabinedecitabineAmneal Pharmaceuticals LLCANDACurrent