Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 207234
Company: NATCO PHARMA LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AZACITIDINE AZACITIDINE 100MG/VIAL POWDER;IV (INFUSION), SUBCUTANEOUS Prescription AP No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/23/2017 ORIG-1 Approval STANDARD

Label is not available on this site.

AZACITIDINE

POWDER;IV (INFUSION), SUBCUTANEOUS; 100MG/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AZACITIDINE AZACITIDINE 100MG/VIAL POWDER;IV (INFUSION), SUBCUTANEOUS Prescription No AP 208216 ACTAVIS LLC
AZACITIDINE AZACITIDINE 100MG/VIAL POWDER;IV (INFUSION), SUBCUTANEOUS Prescription No AP 201537 DR REDDYS LABS LTD
AZACITIDINE AZACITIDINE 100MG/VIAL POWDER;IV (INFUSION), SUBCUTANEOUS Prescription No AP 204949 MYLAN INSTITUTIONAL
AZACITIDINE AZACITIDINE 100MG/VIAL POWDER;IV (INFUSION), SUBCUTANEOUS Prescription No AP 207234 NATCO PHARMA LTD
AZACITIDINE AZACITIDINE 100MG/VIAL POWDER;IV (INFUSION), SUBCUTANEOUS Prescription No AP 207518 SHILPA MEDICARE
VIDAZA AZACITIDINE 100MG/VIAL POWDER;IV (INFUSION), SUBCUTANEOUS Prescription Yes AP 050794 CELGENE

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