List of Extended-Release and Long-Acting Opioid Products Required to Have an Opioid REMS
This information is no longer current.
Please see List of Application Numbers and Sponsors (PDF- 57KB) for current information.
Please see List of Application Numbers and Sponsors (PDF- 57KB) for current information.
Brand Name Products
Trade Name | Generic Name | Sponsor | |
|---|---|---|---|
| 1 | Avinza | Morphine sulfate extended-release capsules | Pfizer |
| 2 | Butrans | Buprenorphine transdermal system | Purdue Pharma |
| 3 | Dolophine | Methadone hydrochloride tablets | Roxane |
| 4 | Duragesic | Fentanyl transdermal system | Janssen Pharmaceuticals |
| 5 | **Embeda | Morphine sulfate and naltrexone extended-release capsules | Pfizer |
| 6 | Exalgo | Hydromorphone hydrochloride extended-release tablets | Mallinckrodt |
| 7 | Kadian | Morphine sulfate extended-release capsules | Actavis |
| 8 | MS Contin | Morphine sulfate controlled-release tablets | Purdue Pharma |
| 9 | Nucynta ER | Tapentadol extended-release oral tablets | Janssen Pharmaceuticals |
| 10 | Opana ER | Oxymorphone hydrochloride extended-release tablets | Endo Pharmaceuticals |
| 11 | OxyContin | Oxycodone hydrochloride controlled-release tablets | Purdue Pharma |
| 12 | *Palladone | Hydromorphone hydrochloride extended-release capsules | Purdue Pharma |
*No longer being marketed, but is still approved.
**Not currently available or marketed due to a voluntary recall, but is still approved.
Generic Products
| Drug Name | Generic Name | Sponsor | |
|---|---|---|---|
| 1 | Fentanyl | Fentanyl extended-release transdermal system | Actavis |
| 2 | Fentanyl | Fentanyl extended-release transdermal system | Lavipharm Labs |
| 3 | Fentanyl | Fentanyl extended-release transdermal system | Mallinckrodt |
| 4 | Fentanyl | Fentanyl extended-release transdermal system | Mylan Technologies |
| 5 | Fentanyl | Fentanyl extended-release transdermal system | Noven |
| 6 | Fentanyl | Fentanyl extended-release transdermal system | Aveva |
| 7 | Fentanyl | Fentanyl extended-release transdermal system | Watson |
| 8 | Methadone Hydrochloride | Methadone hydrochloride concentrate | Roxane |
| 9 | Methadone Hydrochloride | Methadone hydrochloride tablets | The Pharmanetwork |
| 10 | Methadone Hydrochloride | Methadone hydrochloride tablets | Mallinckrodt |
| 11 | Methadone Hydrochloride | Methadone hydrochloride tablets | Sandoz |
| 12 | Methadone Hydrochloride | Methadone hydrochloride oral solution | Roxane |
| 13 | Methadone Hydrochloride | Methadone hydrochloride oral solution | Vistapharm |
| 14 | Morphine Sulfate | Morphine sulfate extended-release capsules | Watson |
| 15 | Morphine Sulfate | Morphine sulfate extended-release tablets | Endo |
| 16 | Morphine Sulfate | Morphine sulfate extended-release tablets | Mallinckrodt |
| 17 | Morphine Sulfate | Morphine sulfate extended-release tablets | Mylan |
| 18 | Morphine Sulfate | Morphine sulfate extended-release tablets | Nesher |
| 19 | Morphine Sulfate | Morphine sulfate extended-release tablets | Ranbaxy |
| 20 | Morphine Sulfate | Morphine sulfate extended-release tablets | Rhodes |
| 21 | Morphine Sulfate | Morphine sulfate extended-release tablets | Watson Labs |
| 22 | Oxymorphone Hydrochloride | Oxymorphone hydrochloride extended-release tablets | Impax |
| 23 | Oxymorphone Hydrochloride | Oxymorphone hydrochloride extended-release tablets | Actavis |
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