Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 209777
Company: DAIICHI SANKYO INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ROXYBOND OXYCODONE HYDROCHLORIDE 5MG TABLET;ORAL Discontinued None No No
ROXYBOND OXYCODONE HYDROCHLORIDE 15MG TABLET;ORAL Discontinued None No No
ROXYBOND OXYCODONE HYDROCHLORIDE 30MG TABLET;ORAL Discontinued None No 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
04/20/2017 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209777lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209777Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209777Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/18/2018 SUPPL-3 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209777s001s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209777Orig1s001s003ltr.pdf
12/31/2018 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209777s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209777Orig1s002ltr.pdf
09/18/2018 SUPPL-1 REMS - PROPOSAL - D-N-A Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209777s001s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209777Orig1s001s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/31/2018 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209777s002lbl.pdf
09/18/2018 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209777s001s003lbl.pdf
09/18/2018 SUPPL-3 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209777s001s003lbl.pdf
09/18/2018 SUPPL-1 REMS - PROPOSAL - D-N-A Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209777s001s003lbl.pdf
04/20/2017 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209777lbl.pdf

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