Opana

NDA 21611, held by Endo Pharms. Oxymorphone Hydrochloride.

As of Nov 15, 2026, NDA 21611 (Opana), held by Endo Pharms, was first approved by FDA on Jun 22, 2006, with 11 approved supplements and 0 published complete response letters.

First approved: Jun 22, 2006
Review: Standard
Supplements approved: 11
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below


Oct 25, 2019	Supplement 16Efficacy (new indication or use) · Standard review	Approved	Letter Label Medication Guide Pediatric Medical Review
Jun 22, 2006	Original applicationNew dosage form · Standard review	Approved	REMS Review Letter Label

Products

2 strengths and forms


Opana5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Oxymorphone Hydrochloride	DiscontinuedReference drug
Opana10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Oxymorphone Hydrochloride	DiscontinuedReference drug

All 12 submissions, including labeling and manufacturing supplements


Oct 25, 2019	Supplement 16Efficacy (new indication or use) · Standard review	Approved	Letter Label Medication Guide Pediatric Medical Review
Oct 7, 2019	Supplement 17Labeling · Standard review	Approved	Label Letter
Sep 18, 2018	Supplement 15Labeling · Standard review	Approved	Label Letter
Sep 18, 2018	Supplement 13REMS	Approved	Label Letter
Dec 22, 2016	Supplement 11Manufacturing · Standard review	Approved	None posted
Dec 16, 2016	Supplement 10Labeling · Standard review	Approved	Label Letter
Sep 17, 2013	Supplement 8Manufacturing · Standard review	Approved	None posted
Jul 9, 2012	Supplement 7Labeling · Standard review	Approved	Label Letter
Feb 3, 2011	Supplement 5Labeling · Standard review	Approved	Letter Label
Apr 15, 2010	Supplement 4Labeling · Standard review	Approved	Letter
Aug 2, 2006	Supplement 1Labeling · Standard review	Approved	Letter Label
Jun 22, 2006	Original applicationNew dosage form · Standard review	Approved	REMS Review Letter Label

Identifiers

Application: NDA 21611
Drugs@FDA: Overview at FDA
Company: Endo Pharmaceuticals

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