Oxycodone Hydrochloride

Manages pain severe enough to require an opioid analgesic. NDA 200535, held by Genus Lifesciences. Oxycodone Hydrochloride.

As of Nov 13, 2026, NDA 200535 (Oxycodone Hydrochloride), held by Genus Lifesciences, was first approved by FDA on Oct 20, 2010, with 17 approved supplements and 0 published complete response letters.

First approved: Oct 20, 2010
Review: Standard
Supplements approved: 17
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Oxycodone Hydrochloride Oral Solution is indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg/mL) is indicated for the relief of pain in opioid-tolerant adults.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below

Date	Submission	Status	Documents
Jul 21, 2021	Supplement 17Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 20, 2010	Original applicationTYPE 7 · Standard review	Approved	REMS Review Summary Review Label

Products

2 strengths and forms

Product	Active ingredient	Marketing
Oxycodone Hydrochloride100MG/5ML · solution;oral	Oxycodone Hydrochloride	RxReference drug
Oxycodone Hydrochloride5MG/5ML · solution;oral	Oxycodone Hydrochloride	RxReference drug

All 18 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jun 18, 2026	Supplement 27REMS	Approved	Letter
Dec 22, 2025	Supplement 26Labeling · Standard review	Approved	Label Letter
Oct 31, 2024	Supplement 24REMS	Approved	Letter
Apr 19, 2024	Supplement 23Labeling · Standard review	Approved	Label Medication Guide Letter
Dec 15, 2023	Supplement 22Labeling · Standard review	Approved	Letter Label
Jul 21, 2021	Supplement 17Efficacy (new indication or use) · Standard review	Approved	Label Letter
Mar 4, 2021	Supplement 19Labeling · Standard review	Approved	Letter Label
Oct 7, 2019	Supplement 16Labeling · Standard review	Approved	Letter Label
Sep 18, 2018	Supplement 14REMS	Approved	Letter Label
Sep 18, 2018	Supplement 15Labeling · Standard review	Approved	Letter Label
Dec 16, 2016	Supplement 11Labeling · Standard review	Approved	Letter Label
Sep 1, 2015	Supplement 10Manufacturing · Standard review	Approved	None posted
Jun 20, 2014	Supplement 9Manufacturing · Standard review	Approved	Label
Oct 8, 2013	Supplement 7Manufacturing · Standard review	Approved	None posted
Aug 22, 2013	Supplement 6Labeling · Standard review	Approved	Letter Label
Aug 22, 2013	Supplement 8Manufacturing · Standard review	Approved	Letter Label
Jan 25, 2012	Supplement 4REMS	Approved	Letter
Oct 20, 2010	Original applicationTYPE 7 · Standard review	Approved	REMS Review Summary Review Label

Identifiers

Application: NDA 200535
Drugs@FDA: Overview at FDA
Company: Genus Lifesciences

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