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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022321
Company: ALPHARMA PHARMS

Medication Guide

FDA Press Release

REMS

FDA has determined that this product has abuse-deterrent properties

Products on NDA 022321

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EMBEDA	MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE	20MG;0.8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
EMBEDA	MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE	30MG;1.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
EMBEDA	MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE	50MG;2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
EMBEDA	MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE	60MG;2.4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
EMBEDA	MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE	80MG;3.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
EMBEDA	MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE	100MG;4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022321

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/13/2009	ORIG-1	Approval	Type 4 - New Combination	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022321s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022321s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022321s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/07/2019	SUPPL-30	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022321s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022321Orig1s030ltr.pdf
09/18/2018	SUPPL-29	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022321s028s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022321Orig1s028s029ltr.pdf
09/18/2018	SUPPL-28	REMS - MODIFIED - D-N-A	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022321s028s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022321Orig1s028s029ltr.pdf
05/26/2017	SUPPL-26	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022321Orig1s026ltr.pdf
09/30/2016	SUPPL-23	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022321Orig1s023ltr.pdf
12/16/2016	SUPPL-22	Labeling-Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022321s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022321Orig1s022ltr.pdf
04/20/2016	SUPPL-21	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022321Orig1s021ltr.pdf
11/10/2015	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
06/26/2015	SUPPL-19	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022321Orig1s019ltr.pdf
08/19/2014	SUPPL-18	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022321Orig1s018ltr.pdf
04/16/2014	SUPPL-17	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022321s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022321Orig1s017ltr.pdf
10/17/2014	SUPPL-16	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022321s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022321Orig1s016ltr.pdf
01/22/2014	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
11/01/2013	SUPPL-13	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022321s013lbl.pdf
06/03/2013	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022321s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022321Orig1s012ltr.pdf
04/15/2013	SUPPL-10	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022321Orig1s010ltr.pdf
01/17/2013	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
07/09/2012	SUPPL-7	Labeling, REMS-Modified	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022321s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022321s007ltr.pdf

Labels for NDA 022321

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/07/2019	SUPPL-30	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022321s030lbl.pdf
10/07/2019	SUPPL-30	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022321s030lbl.pdf
09/18/2018	SUPPL-29	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022321s028s029lbl.pdf
09/18/2018	SUPPL-28	REMS - MODIFIED - D-N-A	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022321s028s029lbl.pdf
12/16/2016	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022321s022lbl.pdf
12/16/2016	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022321s022lbl.pdf
10/17/2014	SUPPL-16	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022321s016lbl.pdf
04/16/2014	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022321s017lbl.pdf
04/16/2014	SUPPL-17	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022321s017lbl.pdf
11/01/2013	SUPPL-13	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022321s013lbl.pdf
06/03/2013	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022321s012lbl.pdf
07/09/2012	SUPPL-7	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022321s007lbl.pdf
07/09/2012	SUPPL-7	REMS-Modified	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022321s007lbl.pdf
08/13/2009	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022321s000lbl.pdf

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