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 22321

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SULFATE; NALTREXONE HYDROCHLORIDE	20MG;0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No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SULFATE; NALTREXONE HYDROCHLORIDE	30MG;1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No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SULFATE; NALTREXONE HYDROCHLORIDE	50MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No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SULFATE; NALTREXONE HYDROCHLORIDE	60MG;2.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No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SULFATE; NALTREXONE HYDROCHLORIDE	80MG;3.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No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SULFATE; NALTREXONE HYDROCHLORIDE	100MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No

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