Active substance
Oxymorphone
- US FDA 18
- Safety 4
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| OXYMORPHONE HYDROCHLORIDE | 5MG; 7.5MG; 10MG; 15MG; 20MG; 30MG; 40MG | tablet, extended release · oral | IMPAX LABS | Prescription | 14 Jun 2010 |
| OXYMORPHONE HYDROCHLORIDE | 5MG; 10MG | tablet · oral | HIKMA PHARMS | Prescription | 27 Sep 2010 |
| OXYMORPHONE HYDROCHLORIDE | 10MG; 5MG | tablet · oral | TEVA | Prescription | 15 Feb 2011 |
| OXYMORPHONE HYDROCHLORIDE | 5MG; 10MG | tablet · oral | AVANTHI INC | Prescription | 30 Jan 2013 |
| OXYMORPHONE HYDROCHLORIDE | 5MG; 10MG | tablet · oral | EPIC PHARMA LLC | Prescription | 15 Dec 2014 |
| OXYMORPHONE HYDROCHLORIDE | 5MG; 10MG | tablet · oral | AUROLIFE PHARMA LLC | Prescription | 26 Apr 2016 |
| OXYMORPHONE HYDROCHLORIDE | 5MG; 10MG | tablet · oral | ASCENT PHARMS INC | Prescription | 2 Feb 2018 |
| OPANA | 1.5MG/ML; 1MG/ML | injectable · injection | ENDO PHARMS | Discontinued | 2 Apr 1959 |
| NUMORPHAN | 5MG | suppository · rectal | ENDO PHARMS | Discontinued | 31 May 1960 |
| OPANA ER | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | tablet, extended release · oral | ENDO OPERATIONS | Discontinued | 22 Jun 2006 |
| OPANA | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | tablet · oral | ENDO PHARMS | Discontinued | 22 Jun 2006 |
| OXYMORPHONE HYDROCHLORIDE | 7.5MG; 15MG; 5MG; 10MG; 20MG; 30MG; 40MG | tablet, extended release · oral | ACTAVIS ELIZABETH | Discontinued | 13 Dec 2010 |
| OPANA ER | 5MG; 7.5MG; 10MG; 15MG; 20MG; 30MG; 40MG | tablet, extended release · oral | ENDO PHARMS | Discontinued | 9 Dec 2011 |
| OXYMORPHONE HYDROCHLORIDE | 5MG; 10MG | tablet · oral | SPECGX LLC | Discontinued | 25 Apr 2013 |
| OXYMORPHONE HYDROCHLORIDE | 40MG; 5MG; 7.5MG; 10MG; 15MG; 20MG; 30MG | tablet, extended release · oral | HIKMA PHARMS | Discontinued | 15 Jul 2013 |
| OXYMORPHONE HYDROCHLORIDE | 5MG; 7.5MG; 10MG; 15MG; 20MG; 30MG; 40MG | tablet, extended release · oral | SPECGX LLC | Discontinued | 27 Jun 2014 |
| OXYMORPHONE HYDROCHLORIDE | 5MG; 7.5MG; 10MG; 15MG; 20MG; 30MG; 40MG | tablet, extended release · oral | PAR PHARM | Discontinued | 24 Oct 2014 |
| OXYMORPHONE HYDROCHLORIDE | 5MG; 7.5MG; 10MG; 15MG; 20MG; 30MG; 40MG | tablet, extended release · oral | SUN PHARM INDS LTD | Discontinued | 24 Apr 2015 |
Safety signals and safety-related labeling changes
- US FDA 15 Dec 2023 OPANA ER — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 25 Oct 2019 OPANA — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 7 Oct 2019 OPANA — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 7 Oct 2019 OPANA ER — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.