Opana Er

NDA 21610, held by Endo Operations. Oxymorphone Hydrochloride.

As of Nov 15, 2026, NDA 21610 (Opana Er), held by Endo Operations, was first approved by FDA on Jun 22, 2006, with 23 approved supplements and 0 published complete response letters.

First approved: Jun 22, 2006
Review: Standard
Supplements approved: 23
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 24 submissions below

Date	Submission	Status	Documents
Jun 22, 2006	Original applicationNew dosage form · Standard review	Approved	Other

Products

7 strengths and forms


Opana Er5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, extended release;oral	Oxymorphone Hydrochloride	DiscontinuedReference drug
Opana Er10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, extended release;oral	Oxymorphone Hydrochloride	DiscontinuedReference drug
Opana Er20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, extended release;oral	Oxymorphone Hydrochloride	DiscontinuedReference drug
Opana Er40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, extended release;oral	Oxymorphone Hydrochloride	DiscontinuedReference drug
Opana Er7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, extended release;oral	Oxymorphone Hydrochloride	DiscontinuedReference drug
Opana Er15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, extended release;oral	Oxymorphone Hydrochloride	DiscontinuedReference drug
Opana Er30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, extended release;oral	Oxymorphone Hydrochloride	DiscontinuedReference drug

All 24 submissions, including labeling and manufacturing supplements


Oct 31, 2024	Supplement 32REMS	Approved	Letter
Dec 15, 2023	Supplement 31Labeling · Standard review	Approved	Letter Label Medication Guide
Apr 28, 2022	Supplement 30Labeling · Standard review	Approved	Letter Label
Mar 4, 2021	Supplement 28Labeling · Standard review	Approved	Label Letter
Oct 7, 2019	Supplement 27Labeling · Standard review	Approved	Label Letter
Sep 18, 2018	Supplement 26Labeling · Standard review	Approved	Label Letter
Sep 18, 2018	Supplement 25REMS	Approved	Label Letter
May 26, 2017	Supplement 24REMS	Approved	Letter
Dec 16, 2016	Supplement 22Labeling · Standard review	Approved	Label Letter
Sep 30, 2016	Supplement 23REMS	Approved	Letter
Apr 20, 2016	Supplement 21REMS	Approved	Letter
Jun 26, 2015	Supplement 20REMS	Approved	Letter
Aug 19, 2014	Supplement 19REMS	Approved	Letter
Apr 16, 2014	Supplement 18Labeling	Approved	Letter Label
Feb 23, 2014	Supplement 17Manufacturing · Standard review	Approved	None posted
Apr 15, 2013	Supplement 14REMS	Approved	Letter
Jul 9, 2012	Supplement 13Labeling	Approved	Label Letter
Jul 9, 2012	Supplement 12REMS	Approved	Label Letter
Oct 4, 2010	Supplement 9Labeling · Standard review	Approved	Letter Label
Feb 29, 2008	Supplement 6Manufacturing	Approved	Letter Label
Jan 10, 2008	Supplement 5Manufacturing	Approved	Letter Label
Jul 9, 2007	Supplement 3Labeling · Standard review	Approved	Letter Label
Aug 2, 2006	Supplement 1Labeling · Standard review	Approved	Letter Label
Jun 22, 2006	Original applicationNew dosage form · Standard review	Approved	Other

Identifiers

Application: NDA 21610
Drugs@FDA: Overview at FDA
Company: Endo Operations

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