Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021790
Company: OTSUKA
Company: OTSUKA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DACOGEN | DECITABINE | 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INTRAVENOUS | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
05/02/2006 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021790lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021790s000LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021790s000_DacogenTOC.cfm |
Supplements
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)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021790s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021790Orig1s025ltr.pdf | |
02/25/2020 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021790Orig1s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021790Orig1s023ltr.pdf | |
12/21/2018 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021790s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021790Orig1s021Ltr.pdf | |
12/11/2018 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021790s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021790Orig1s020ltr.pdf | |
03/08/2016 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/07/2015 | SUPPL-18 | Manufacturing (CMC) |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021790s018lbl.pdf | |
01/15/2014 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/06/2013 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/11/2010 | SUPPL-6 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021790s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021790s006ltr.pdf |
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/2020/021790Orig1s023lbl.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 |