FDA.reportPublic FDA data

Application 207234

Type
ANDA
Sponsor
NATCO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AZACITIDINEAZACITIDINEPOWDER;INTRAVENOUS, SUBCUTANEOUS100MG/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43598-143AzacitidineAzacitidineDr. Reddy's Laboratories Inc.ANDACurrent
43817-906AzacitidineAzacitidinePanacea Biotec Ltd.ANDACurrent
43817-906AzacitidineAzacitidinePanacea Biotec LimitedANDACurrent
51991-797AzacitidineAzacitidineBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-797AzacitidineAzacitidineBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-797AzacitidineAzacitidineBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-797AzacitidineAzacitidineBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-797AzacitidineAzacitidineBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-797AzacitidineAzacitidineBreckenridge Pharmaceutical, Inc.ANDACurrent
68001-504AzacitidineAzacitidineBluePoint LaboratoriesANDACurrent