Numorphan

NDA 11738, held by Endo Pharms. Oxymorphone Hydrochloride.

As of Nov 14, 2026, NDA 11738 (Numorphan), held by Endo Pharms, was first approved by FDA on May 31, 1960, with 5 approved supplements and 0 published complete response letters.

First approved: May 31, 1960
Review: Standard
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
May 31, 1960	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Numorphan5MG · suppository;rectal	Oxymorphone Hydrochloride	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Sep 25, 2000	Supplement 12Manufacturing · Standard review	Approved	None posted
Oct 29, 1997	Supplement 13Labeling · Standard review	Approved	None posted
Oct 15, 1996	Supplement 11Labeling · Standard review	Approved	None posted
May 11, 1994	Supplement 10Manufacturing · Standard review	Approved	None posted
Nov 4, 1981	Supplement 7Manufacturing · Standard review	Approved	None posted
May 31, 1960	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 11738
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