FDA.reportPublic FDA data

Application 201537

Type
ANDA
Sponsor
DR REDDYS

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
16714-927AzacitidineAzacitidineNorthStar RxLLCANDACurrent
16714-927AzacitidineAzacitidineNorthStar RxLLCANDACurrent
16714-927AzacitidineAzacitidineNorthStar RxLLCANDACurrent
16714-927AzacitidineAzacitidineNorthStar RxLLCANDACurrent
43598-305AzacitidineAzacitidineDr. Reddy's Laboratories Inc.ANDACurrent
43598-305AzacitidineAzacitidineDr. Reddy's Laboratories Inc.ANDACurrent
43598-305AzacitidineAzacitidineDr. Reddy's Laboratories Inc.ANDACurrent
43598-465AzacitidineAzacitidineDr. Reddy's Laboratories Inc.ANDACurrent
43598-465AzacitidineAzacitidineDr. Reddy's Laboratories Inc.ANDACurrent
43598-465AzacitidineAzacitidineDr. Reddy's Laboratories Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9910ORIG2013-09-19