Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 202080
Company: ZYLA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OXAYDO OXYCODONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription None No No
OXAYDO OXYCODONE HYDROCHLORIDE 7.5MG TABLET;ORAL Prescription 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
06/17/2011 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202080s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202080s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202080_oxecta_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/07/2019 SUPPL-11 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202080s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/202080Orig1s011ltr.pdf
09/18/2018 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202080s009s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202080Orig1s009s010ltr.pdf
09/18/2018 SUPPL-9 REMS - PROPOSAL - D-N-A Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202080s009s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202080Orig1s009s010ltr.pdf
12/16/2016 SUPPL-6 Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202080s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202080Orig1s005,s006ltr.pdf
12/16/2016 SUPPL-5 Labeling-Medication Guide, Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202080s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202080Orig1s005,s006ltr.pdf
03/07/2016 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

01/26/2015 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202080Orig1s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202080Orig1s003ltr.pdf
01/16/2014 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202080s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202080Origs002ltr.pdf
06/03/2013 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202080s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202080Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/07/2019 SUPPL-11 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202080s011lbl.pdf
10/07/2019 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202080s011lbl.pdf
09/18/2018 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202080s009s010lbl.pdf
09/18/2018 SUPPL-9 REMS - PROPOSAL - D-N-A Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202080s009s010lbl.pdf
12/16/2016 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202080s005s006lbl.pdf
12/16/2016 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202080s005s006lbl.pdf
12/16/2016 SUPPL-5 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202080s005s006lbl.pdf
12/16/2016 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202080s005s006lbl.pdf
12/16/2016 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202080s005s006lbl.pdf
01/26/2015 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202080Orig1s003lbl.pdf
01/16/2014 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202080s002lbl.pdf
06/03/2013 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202080s001lbl.pdf
06/17/2011 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202080s000lbl.pdf

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