FDA Approved Opioid Products
Abuse Deterrent Labeling
April 16, 2013: a Reformulated Oxycontin
July 23, 2014: New Extended-release Oxycodone
October 17, 2014: Embeda (morphine sulfate and naltrexone hydrochloride) Extended-release (ER) Capsules.
- Label and FDA Approval History for Embeda (morphine sulfate and naltrexone hydrochloride) Extended-release (ER) Capsules.
- DailyMed Label Here
November 20, 2014: Hysingla ER (hydrocodone bitartrate), Extended-release, Single-entity Hydrocodone Product
FDA Approved Opioid Products Without Abuse Deterrent Labeling
October 25, 2013: Zohydro ER, a Schedule II controlled substance under the Controlled Substances Act
FDA Approval Information for Opioid Products with Abuse Deterrent Labeling