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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021790
Company: OTSUKA

Products on NDA 021790

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DACOGEN	DECITABINE	50MG/VIAL	INJECTABLE;INTRAVENOUS	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021790

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)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021790s023lbl.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

Labels for NDA 021790

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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