Embeda

NDA 22321, held by Alpharma Pharms. Morphine Sulfate; Naltrexone Hydrochloride.

As of Nov 15, 2026, NDA 22321 (Embeda), held by Alpharma Pharms, was first approved by FDA on Aug 13, 2009, with 18 approved supplements and 0 published complete response letters.

First approved: Aug 13, 2009
Review: Priority
Supplements approved: 18
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below


Oct 17, 2014	Supplement 16Efficacy (new indication or use) · Standard review	Approved	Label Letter
Aug 13, 2009	Original applicationNew combination · Priority review	Approved	Other Review Letter Label

Products

6 strengths and forms


Embeda20MG;0.8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule, extended release;oral	Morphine Sulfate; Naltrexone Hydrochloride	DiscontinuedReference drug
Embeda30MG;1.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule, extended release;oral	Morphine Sulfate; Naltrexone Hydrochloride	DiscontinuedReference drug
Embeda50MG;2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule, extended release;oral	Morphine Sulfate; Naltrexone Hydrochloride	DiscontinuedReference drug
Embeda60MG;2.4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule, extended release;oral	Morphine Sulfate; Naltrexone Hydrochloride	DiscontinuedReference drug
Embeda80MG;3.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule, extended release;oral	Morphine Sulfate; Naltrexone Hydrochloride	DiscontinuedReference drug
Embeda100MG;4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule, extended release;oral	Morphine Sulfate; Naltrexone Hydrochloride	DiscontinuedReference drug

All 19 submissions, including labeling and manufacturing supplements


Oct 7, 2019	Supplement 30Labeling · Standard review	Approved	Letter Label Medication Guide
Sep 18, 2018	Supplement 29Labeling · Standard review	Approved	Letter Label Medication Guide
Sep 18, 2018	Supplement 28REMS	Approved	Letter Label Medication Guide
May 26, 2017	Supplement 26REMS	Approved	Letter
Dec 16, 2016	Supplement 22Labeling · Standard review	Approved	Letter Label
Sep 30, 2016	Supplement 23REMS	Approved	Letter
Apr 20, 2016	Supplement 21REMS	Approved	Letter
Nov 10, 2015	Supplement 20Manufacturing · Priority review	Approved	None posted
Jun 26, 2015	Supplement 19REMS	Approved	Letter
Oct 17, 2014	Supplement 16Efficacy (new indication or use) · Standard review	Approved	Label Letter
Aug 19, 2014	Supplement 18REMS	Approved	Letter
Apr 16, 2014	Supplement 17Labeling	Approved	Letter Label
Jan 22, 2014	Supplement 15Manufacturing · Priority review	Approved	None posted
Nov 1, 2013	Supplement 13Manufacturing · Priority review	Approved	Label
Jun 3, 2013	Supplement 12Labeling · Standard review	Approved	Letter Label
Apr 15, 2013	Supplement 10REMS	Approved	Letter
Jan 17, 2013	Supplement 8Manufacturing · Priority review	Approved	None posted
Jul 9, 2012	Supplement 7Labeling · Standard review	Approved	Label Letter
Aug 13, 2009	Original applicationNew combination · Priority review	Approved	Other Review Letter Label

Identifiers

Application: NDA 22321
Drugs@FDA: Overview at FDA
Company: Alpharma

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