Oxycontin

Manages severe and persistent pain. NDA 22272, held by Knoa Pharma. Oxycodone Hydrochloride.

As of Nov 13, 2026, NDA 22272 (Oxycontin), held by Knoa Pharma, was first approved by FDA on Apr 5, 2010, with 35 approved supplements and 0 published complete response letters.

First approved: Apr 5, 2010
Review: Priority
Supplements approved: 35
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

OXYCONTIN is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids, in: Adults; and Opioid-tolerant pediatric patients 11 years of age and older who are already receiving and tolerate a minimum daily opioid dose of at least 20 mg oxycodone orally or its equivalent.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 36 submissions below


Aug 13, 2015	Supplement 27Efficacy (new indication or use) · Priority review	Approved	Review Label Letter
Apr 16, 2013	Supplement 14Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Apr 5, 2010	Original applicationNew formulation or manufacturer · Priority review	Approved	Summary Review Review Other Letter

Products

7 strengths and forms


Oxycontin10MG · tablet, extended release;oral	Oxycodone Hydrochloride	RxReference drug
Oxycontin15MG · tablet, extended release;oral	Oxycodone Hydrochloride	RxReference drug
Oxycontin20MG · tablet, extended release;oral	Oxycodone Hydrochloride	RxReference drug
Oxycontin30MG · tablet, extended release;oral	Oxycodone Hydrochloride	RxReference drug
Oxycontin40MG · tablet, extended release;oral	Oxycodone Hydrochloride	RxReference drug
Oxycontin60MG · tablet, extended release;oral	Oxycodone Hydrochloride	RxReference drug
Oxycontin80MG · tablet, extended release;oral	Oxycodone Hydrochloride	RxReference drug

All 36 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 53REMS	Approved	Letter
Dec 22, 2025	Supplement 52Labeling · Standard review	Approved	Label Letter
Oct 31, 2024	Supplement 49REMS	Approved	Letter
Dec 15, 2023	Supplement 48Labeling · Standard review	Approved	Letter Label Medication Guide
Oct 28, 2021	Supplement 47Labeling · Standard review	Approved	Letter Label
Mar 4, 2021	Supplement 46Labeling · Standard review	Approved	Label Letter
Nov 14, 2019	Supplement 42REMS	Approved	Letter
Oct 7, 2019	Supplement 43Labeling · Standard review	Approved	Letter Label
Sep 26, 2018	Supplement 39Labeling · Standard review	Approved	Letter Label
Sep 18, 2018	Supplement 41Labeling · Standard review	Approved	Letter Label
Sep 18, 2018	Supplement 40REMS	Approved	Letter Label
May 26, 2017	Supplement 37REMS	Approved	Letter
Dec 16, 2016	Supplement 34Labeling · Standard review	Approved	Label Letter
Sep 30, 2016	Supplement 36REMS	Approved	Letter
Apr 20, 2016	Supplement 33REMS	Approved	None posted
Mar 28, 2016	Supplement 32Manufacturing · Priority review	Approved	None posted
Mar 25, 2016	Supplement 31Manufacturing · Priority review	Approved	None posted
Nov 12, 2015	Supplement 30Manufacturing · Priority review	Approved	None posted
Sep 10, 2015	Supplement 29Manufacturing · Priority review	Approved	None posted
Aug 13, 2015	Supplement 27Efficacy (new indication or use) · Priority review	Approved	Review Label Letter
Jun 26, 2015	Supplement 28REMS	Approved	Letter
Oct 22, 2014	Supplement 23Labeling · Standard review	Approved	Label Letter
Oct 13, 2014	Supplement 25Manufacturing · Priority review	Approved	None posted
Aug 19, 2014	Supplement 24REMS	Approved	Letter
Apr 16, 2014	Supplement 22Labeling	Approved	Letter Label
Feb 4, 2014	Supplement 15Manufacturing · Priority review	Approved	None posted
Jan 31, 2014	Supplement 20Manufacturing · Priority review	Approved	None posted
Apr 16, 2013	Supplement 14Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Apr 15, 2013	Supplement 17REMS	Approved	Letter
Jan 11, 2013	Supplement 16Labeling · Standard review	Approved	Label Letter
Jul 9, 2012	Supplement 11Labeling · Standard review	Approved	Label Letter
Jul 9, 2012	Supplement 10Labeling · Standard review	Approved	Label Letter
Oct 5, 2011	Supplement 9Labeling	Approved	Label Letter
Nov 15, 2010	Supplement 6Labeling	Approved	Label Letter
Jun 29, 2010	Supplement 5REMS	Approved	Letter Label
Apr 5, 2010	Original applicationNew formulation or manufacturer · Priority review	Approved	Summary Review Review Other Letter

Identifiers

Application: NDA 22272
Drugs@FDA: Overview at FDA
Company: KNOA Pharma

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters