Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 021790
Company: OTSUKA PHARM CO LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DACOGEN DECITABINE 50MG/VIAL INJECTABLE;INTRAVENOUS Prescription AP 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
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
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
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

DACOGEN

INJECTABLE;INTRAVENOUS; 50MG/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DACOGEN DECITABINE 50MG/VIAL INJECTABLE;INTRAVENOUS Prescription Yes AP 021790 OTSUKA PHARM CO LTD
DECITABINE DECITABINE 50MG/VIAL INJECTABLE;INTRAVENOUS Prescription No AP 203475 ACCORD HLTHCARE
DECITABINE DECITABINE 50MG/VIAL INJECTABLE;INTRAVENOUS Prescription No AP 206033 CHEMI SPA
DECITABINE DECITABINE 50MG/VIAL INJECTABLE;INTRAVENOUS Prescription No AP 208601 CIPLA
DECITABINE DECITABINE 50MG/VIAL INJECTABLE;INTRAVENOUS Prescription No AP 203131 DR REDDYS
DECITABINE DECITABINE 50MG/VIAL INJECTABLE;INTRAVENOUS Prescription No AP 210984 INGENUS PHARMS LLC
DECITABINE DECITABINE 50MG/VIAL INJECTABLE;INTRAVENOUS Prescription No AP 210756 LUPIN LTD
DECITABINE DECITABINE 50MG/VIAL INJECTABLE;INTRAVENOUS Prescription No AP 212265 MSN LABS PVT LTD
DECITABINE DECITABINE 50MG/VIAL INJECTABLE;INTRAVENOUS Prescription No AP 204607 PHARMASCIENCE INC
DECITABINE DECITABINE 50MG/VIAL INJECTABLE;INTRAVENOUS Prescription No AP 207100 SAGENT PHARMS INC
DECITABINE DECITABINE 50MG/VIAL INJECTABLE;INTRAVENOUS Prescription No AP 202969 SANDOZ INC
DECITABINE DECITABINE 50MG/VIAL INJECTABLE;INTRAVENOUS Prescription No AP 209056 WOCKHARDT BIO AG

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English