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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021790
Company: OTSUKA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DACOGEN DECITABINE 50MG/VIAL INJECTABLE;INTRAVENOUS Prescription AP Yes Yes
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/29/2020 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021790s025lbl.pdf
02/25/2020 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021790s023lbl.pdf
12/21/2018 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021790s021lbl.pdf
12/11/2018 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021790s020lbl.pdf
04/07/2015 SUPPL-18 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021790s018lbl.pdf
03/11/2010 SUPPL-6 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021790s006lbl.pdf
05/02/2006 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021790lbl.pdf
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