ROXYBOND (OXYCODONE HYDROCHLORIDE)
Summary
FDA approved ROXYBOND (OXYCODONE HYDROCHLORIDE) by PROTEGA PHARMS. NDA (New Drug) approval (REMS) on 2026-06-18. TABLET, ORAL.
Details
Source
Drug Approval
External ID
NDA209777-16
Action Date
2026-06-18
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
ROXYBOND (generic: OXYCODONE HYDROCHLORIDE), TABLET, ORAL. Application: NDA209777
Company
Context & Analysis
Frequently Asked Questions
How often does PROTEGA PHARMS have FDA actions?
This is the only FDA action we have on record for PROTEGA PHARMS in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "NDA209777-16" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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