Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020616
Company: ALLERGAN
Company: ALLERGAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| KADIAN | MORPHINE SULFATE | 20MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
| KADIAN | MORPHINE SULFATE | 50MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
| KADIAN | MORPHINE SULFATE | 100MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
| KADIAN | MORPHINE SULFATE | 30MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
| KADIAN | MORPHINE SULFATE | 60MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
| KADIAN | MORPHINE SULFATE | 80MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
| KADIAN | MORPHINE SULFATE | 200MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
| KADIAN | MORPHINE SULFATE | 10MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
| KADIAN | MORPHINE SULFATE | 40MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
| KADIAN | MORPHINE SULFATE | 70MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
| KADIAN | MORPHINE SULFATE | 130MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
| KADIAN | MORPHINE SULFATE | 150MG | 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 |
|---|---|---|---|---|---|---|---|
| 07/03/1996 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/04/2021 | SUPPL-65 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020616s065lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020616Orig1s065ltr.pdf | |
| 10/07/2019 | SUPPL-63 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020616s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020616Orig1s063ltr.pdf | |
| 09/18/2018 | SUPPL-62 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020616s061s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020616Orig1s061s062ltr.pdf | |
| 09/18/2018 | SUPPL-61 | REMS - MODIFIED - D-N-A |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020616s061s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020616Orig1s061s062ltr.pdf | |
| 05/26/2017 | SUPPL-60 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020616Orig1s060ltr.pdf |
| 09/30/2016 | SUPPL-58 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020616Orig1s058ltr.pdf |
| 12/16/2016 | SUPPL-57 | Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020616s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020616Orig1s057ltr.pdf | |
| 04/20/2016 | SUPPL-55 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020616Orig1s055ltr.pdf |
| 06/26/2015 | SUPPL-54 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020616Orig1s054ltr.pdf |
| 08/19/2014 | SUPPL-53 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020616Orig1s053ltr.pdf |
| 04/14/2014 | SUPPL-52 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/16/2014 | SUPPL-51 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020616s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020616Orig1s051ltr.pdf | |
| 03/27/2013 | SUPPL-48 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020616Orig1s048ltr.pdf |
| 04/15/2013 | SUPPL-47 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020616Orig1s047ltr.pdf |
| 01/14/2013 | SUPPL-46 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/09/2012 | SUPPL-44 | Manufacturing (CMC) |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020616s036s044lbl.pdf | |
| 07/09/2012 | SUPPL-41 | REMS-Proposal |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020616s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020616Orig1s041ltr.pdf | |
| 07/09/2012 | SUPPL-36 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/31/2008 | SUPPL-28 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/20/2007 | SUPPL-25 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020616s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020616s025ltr.pdf | |
| 10/27/2006 | SUPPL-22 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020616s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020616s022ltr.pdf | |
| 02/27/2007 | SUPPL-21 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020616s017s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020616s017, s021ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/020616_S021_KADIAN.pdf | |
| 02/27/2007 | SUPPL-17 | Manufacturing (CMC)-Formulation |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020616s017s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020616s017, s021ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/020616_S017_KADIAN.pdf | |
| 09/28/2005 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020616s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020616s010ltr.pdf | |
| 03/28/2002 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/18/2001 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/21/2001 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/08/2001 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/28/2000 | SUPPL-5 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 03/09/2001 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/16/1999 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 04/08/1998 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/29/1997 | SUPPL-1 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020616S1_Kadian.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/04/2021 | SUPPL-65 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020616s065lbl.pdf | |
| 10/07/2019 | SUPPL-63 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020616s063lbl.pdf | |
| 10/07/2019 | SUPPL-63 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020616s063lbl.pdf | |
| 09/18/2018 | SUPPL-62 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020616s061s062lbl.pdf | |
| 09/18/2018 | SUPPL-61 | REMS - MODIFIED - D-N-A | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020616s061s062lbl.pdf | |
| 12/16/2016 | SUPPL-57 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020616s057lbl.pdf | |
| 12/16/2016 | SUPPL-57 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020616s057lbl.pdf | |
| 04/16/2014 | SUPPL-51 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020616s051lbl.pdf | |
| 04/16/2014 | SUPPL-51 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020616s051lbl.pdf | |
| 07/09/2012 | SUPPL-44 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020616s036s044lbl.pdf |
| 07/09/2012 | SUPPL-41 | REMS-Proposal | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020616s041lbl.pdf | |
| 04/20/2007 | SUPPL-25 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020616s025lbl.pdf | |
| 04/20/2007 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020616s025lbl.pdf | |
| 02/27/2007 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020616s017s021lbl.pdf | |
| 02/27/2007 | SUPPL-17 | Manufacturing (CMC)-Formulation | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020616s017s021lbl.pdf | |
| 10/27/2006 | SUPPL-22 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020616s022lbl.pdf | |
| 10/27/2006 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020616s022lbl.pdf | |
| 09/28/2005 | SUPPL-10 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020616s010lbl.pdf |