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U.S. Department of Health and Human Services

Drugs

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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This information is no longer current.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) for current information.


Brand Name Products

 

Trade Name

Generic Name

Sponsor

1AvinzaMorphine sulfate extended-release capsulesPfizer
2ButransBuprenorphine transdermal systemPurdue Pharma
3DolophineMethadone hydrochloride tabletsRoxane
4DuragesicFentanyl transdermal systemJanssen Pharmaceuticals
5**EmbedaMorphine sulfate and naltrexone extended-release capsulesPfizer
6ExalgoHydromorphone hydrochloride extended-release tabletsMallinckrodt
7Kadian Morphine sulfate extended-release capsulesActavis
8MS ContinMorphine sulfate controlled-release tabletsPurdue Pharma
9Nucynta ERTapentadol extended-release oral tabletsJanssen Pharmaceuticals
10Opana EROxymorphone hydrochloride extended-release tabletsEndo Pharmaceuticals
11OxyContinOxycodone hydrochloride controlled-release tabletsPurdue Pharma
12*PalladoneHydromorphone hydrochloride extended-release capsulesPurdue 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

8Methadone HydrochlorideMethadone hydrochloride concentrateRoxane

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

14Morphine SulfateMorphine sulfate extended-release capsulesWatson

15

Morphine Sulfate

Morphine sulfate extended-release tablets

Endo

16

Morphine Sulfate

Morphine sulfate extended-release tablets

Mallinckrodt

17Morphine SulfateMorphine sulfate extended-release tabletsMylan
18Morphine SulfateMorphine sulfate extended-release tabletsNesher
19Morphine SulfateMorphine sulfate extended-release tabletsRanbaxy

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


Back to REMS for Extended-Release and Long-Acting Opioid Drugs