Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 022321
Company: ALPHARMA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EMBEDA MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE 20MG;0.8MG CAPSULE, EXTENDED RELEASE;ORAL Prescription None Yes No
EMBEDA MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE 30MG;1.2MG CAPSULE, EXTENDED RELEASE;ORAL Prescription None Yes No
EMBEDA MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE 50MG;2MG CAPSULE, EXTENDED RELEASE;ORAL Prescription None Yes No
EMBEDA MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE 60MG;2.4MG CAPSULE, EXTENDED RELEASE;ORAL Prescription None Yes Yes
EMBEDA MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE 80MG;3.2MG CAPSULE, EXTENDED RELEASE;ORAL Prescription None Yes No
EMBEDA MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE 100MG;4MG CAPSULE, EXTENDED RELEASE;ORAL Prescription None Yes No
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-Medication Guide, Labeling-Package Insert 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
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-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022321s017lbl.pdf
04/16/2014 SUPPL-17 Labeling-Package Insert 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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English