Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022321
Company: ALPHARMA PHARMS
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SULFATE; NALTREXONE HYDROCHLORIDE | 20MG;0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |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SULFATE; NALTREXONE HYDROCHLORIDE | 30MG;1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |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SULFATE; NALTREXONE HYDROCHLORIDE | 50MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |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SULFATE; NALTREXONE HYDROCHLORIDE | 60MG;2.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |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SULFATE; NALTREXONE HYDROCHLORIDE | 80MG;3.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |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SULFATE; NALTREXONE HYDROCHLORIDE | 100MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
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 |
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 |