General MedicationsORALStandard
OXYCONTIN
OXYCODONE HYDROCHLORIDE
Standard Dose
15MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview OXYCONTIN is listed in Drugs@FDA under application 022272 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient OXYCODONE HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - 15MG Sponsor PURDUE PHARMA LP Submission history Latest submission status date: 2025-12-22 00:00:00.
Structured Monograph
Clinical summary
Approval overview OXYCONTIN is listed in Drugs@FDA under application 022272 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient OXYCODONE HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - 15MG Sponsor PURDUE PHARMA LP Submission history Latest submission status date: 2025-12-22 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.