Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205582
Company: SUN PHARMA GLOBAL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DECITABINE DECITABINE 50MG/VIAL POWDER;INTRAVENOUS Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/23/2014 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205582s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205582Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205582Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205582Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/16/2020 SUPPL-15 Labeling-Package Insert, Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205582s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/205582Orig1s015ltr.pdf
05/21/2020 SUPPL-14 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205582s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/205582Orig1s014ltr.pdf
02/03/2020 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205582s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/205582Orig1s012ltr.pdf
05/22/2019 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205582s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205582Orig1s009ltr.pdf
03/16/2016 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

08/14/2014 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/16/2020 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205582s015lbl.pdf
09/16/2020 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205582s015lbl.pdf
05/21/2020 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205582s014lbl.pdf
02/03/2020 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205582s012lbl.pdf
05/22/2019 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205582s009lbl.pdf
01/23/2014 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205582s000lbl.pdf

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