An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 209777
Company: PROTEGA PHARMS

Medication Guide

FDA has determined that this product has abuse-deterrent properties

REMS

Products on NDA 209777

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ROXYBOND	OXYCODONE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	None	No	No
ROXYBOND	OXYCODONE HYDROCHLORIDE	15MG	TABLET;ORAL	Prescription	None	No	No
ROXYBOND	OXYCODONE HYDROCHLORIDE	30MG	TABLET;ORAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 209777

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
04/19/2024	SUPPL-9	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209777s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/209777Orig1s009ltr.pdf
12/15/2023	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209777s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209777Orig1s008ltr.pdf
03/04/2021	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209777s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209777Orig1s007ltr.pdf
10/07/2019	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209777s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209777Orig1s006ltr.pdf
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

Labels for NDA 209777

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/19/2024	SUPPL-9	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209777s009lbl.pdf
04/19/2024	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209777s009lbl.pdf
12/15/2023	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209777s008lbl.pdf
03/04/2021	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209777s007lbl.pdf
10/07/2019	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209777s006lbl.pdf
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

Top