Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 208216
Company: ACTAVIS LLC
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
04/29/2016 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208216s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208216Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208216Orig1s000TOC.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/29/2016 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208216s000lbl.pdf

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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