Opana

NDA 11707, held by Endo Pharms. Oxymorphone Hydrochloride.

As of Nov 14, 2026, NDA 11707 (Opana), held by Endo Pharms, was first approved by FDA on Apr 2, 1959, with 19 approved supplements and 0 published complete response letters.

First approved: Apr 2, 1959
Review: Standard
Supplements approved: 19
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below

Date	Submission	Status	Documents
Apr 2, 1959	Original applicationNew dosage form · Standard review	Approved	None posted

Products

2 strengths and forms


Opana1.5MG/ML · injectable;injection	Oxymorphone Hydrochloride	Discontinued
Opana1MG/ML · injectable;injection	Oxymorphone Hydrochloride	DiscontinuedReference drug

All 20 submissions, including labeling and manufacturing supplements


Oct 7, 2019	Supplement 37Labeling · Standard review	Approved	Letter Label
Dec 16, 2016	Supplement 36Labeling · Standard review	Approved	Label Letter
Oct 16, 2006	Supplement 31Labeling · Standard review	Approved	Letter Label
Oct 25, 2002	Supplement 29Manufacturing · Standard review	Approved	None posted
Apr 16, 2002	Supplement 27Manufacturing · Standard review	Approved	None posted
Jan 15, 2002	Supplement 28Manufacturing · Standard review	Approved	None posted
Sep 25, 2000	Supplement 24Manufacturing · Standard review	Approved	None posted
Oct 29, 1997	Supplement 26Labeling · Standard review	Approved	None posted
Aug 6, 1997	Supplement 25Manufacturing · Standard review	Approved	None posted
Oct 15, 1996	Supplement 23Labeling · Standard review	Approved	None posted
Aug 11, 1994	Supplement 22Manufacturing · Standard review	Approved	None posted
May 11, 1994	Supplement 21Manufacturing · Standard review	Approved	None posted
Aug 24, 1993	Supplement 17Manufacturing · Standard review	Approved	None posted
Dec 8, 1987	Supplement 20Manufacturing · Standard review	Approved	None posted
Aug 31, 1983	Supplement 16Manufacturing · Standard review	Approved	None posted
Aug 31, 1983	Supplement 15Manufacturing · Standard review	Approved	None posted
Nov 9, 1981	Supplement 13Manufacturing · Standard review	Approved	None posted
Apr 1, 1981	Supplement 11Manufacturing · Standard review	Approved	None posted
Mar 26, 1976	Supplement 8Labeling	Approved	None posted
Apr 2, 1959	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 11707
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