Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019516
Company: PURDUE PHARMA LP
Company: PURDUE PHARMA LP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MS CONTIN | MORPHINE SULFATE | 30MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| MS CONTIN | MORPHINE SULFATE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| MS CONTIN | MORPHINE SULFATE | 15MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| MS CONTIN | MORPHINE SULFATE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | Yes |
| MS CONTIN | MORPHINE SULFATE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 05/29/1987 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/15/2023 | SUPPL-58 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019516s058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/019516Orig1s058ltr.pdf | |
| 03/04/2021 | SUPPL-57 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019516s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/019516Orig1s057ltr.pdf | |
| 10/07/2019 | SUPPL-55 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019516s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019516Orig1s055ltr.pdf | |
| 09/18/2018 | SUPPL-54 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019516s053s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019516Orig1s053s054ltr.pdf | |
| 09/18/2018 | SUPPL-53 | REMS - MODIFIED - D-N-A |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019516s053s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019516Orig1s053s054ltr.pdf | |
| 05/26/2017 | SUPPL-52 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019516Orig1s052ltr.pdf |
| 09/30/2016 | SUPPL-50 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019516Orig1s050ltr.pdf |
| 12/16/2016 | SUPPL-49 | Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019516s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019516Orig1s049ltr.pdf | |
| 04/20/2016 | SUPPL-47 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019516Orig1s047ltr.pdf |
| 06/26/2015 | SUPPL-46 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019516Orig1s046ltr.pdf |
| 08/19/2014 | SUPPL-44 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019516Orig1s044ltr.pdf |
| 10/22/2014 | SUPPL-43 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019516Orig1s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019516Orig1s043,022272Orig1s023ltr.pdf | |
| 04/16/2014 | SUPPL-42 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019516s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019516Orig1s042ltr.pdf | |
| 06/02/2014 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/15/2013 | SUPPL-38 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019516Orig1s038ltr.pdf |
| 07/09/2012 | SUPPL-37 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019516s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019516Orig1s037ltr.pdf | |
| 07/09/2012 | SUPPL-36 | REMS-Proposal |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019516s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019516Orig1s036ltr.pdf | |
| 05/11/2010 | SUPPL-34 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019516s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019516s034ltr.pdf | |
| 05/11/2007 | SUPPL-30 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019516s030ltr.pdf |
| 08/06/2003 | SUPPL-21 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19516slr021ltr.pdf |
| 02/21/2003 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19516scp019ltr.pdf |
| 12/18/2001 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 02/12/2001 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 05/02/2000 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/27/2000 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/02/2000 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/02/2000 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/02/2000 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/02/2000 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/12/2000 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/29/1997 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/12/1990 | SUPPL-6 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 05/02/1988 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/08/1993 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/16/1990 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/12/1989 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/08/1988 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/15/2023 | SUPPL-58 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019516s058lbl.pdf | |
| 03/04/2021 | SUPPL-57 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019516s057lbl.pdf | |
| 10/07/2019 | SUPPL-55 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019516s055lbl.pdf | |
| 10/07/2019 | SUPPL-55 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019516s055lbl.pdf | |
| 09/18/2018 | SUPPL-54 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019516s053s054lbl.pdf | |
| 09/18/2018 | SUPPL-54 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019516s053s054lbl.pdf | |
| 09/18/2018 | SUPPL-53 | REMS - MODIFIED - D-N-A | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019516s053s054lbl.pdf | |
| 12/16/2016 | SUPPL-49 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019516s049lbl.pdf | |
| 12/16/2016 | SUPPL-49 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019516s049lbl.pdf | |
| 10/22/2014 | SUPPL-43 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019516Orig1s043lbl.pdf | |
| 04/16/2014 | SUPPL-42 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019516s042lbl.pdf | |
| 04/16/2014 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019516s042lbl.pdf | |
| 07/09/2012 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019516s037lbl.pdf | |
| 07/09/2012 | SUPPL-36 | REMS-Proposal | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019516s036lbl.pdf | |
| 05/11/2010 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019516s034lbl.pdf |
MS CONTIN
TABLET, EXTENDED RELEASE;ORAL; 30MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MORPHINE SULFATE | MORPHINE SULFATE | 30MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203849 | ACTAVIS ELIZABETH |
| MORPHINE SULFATE | MORPHINE SULFATE | 30MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203602 | NOVEL LABS INC |
| MORPHINE SULFATE | MORPHINE SULFATE | 30MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 074862 | RHODES PHARMS |
| MORPHINE SULFATE | MORPHINE SULFATE | 30MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 076412 | SPECGX LLC |
| MORPHINE SULFATE | MORPHINE SULFATE | 30MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 075295 | STRIDES PHARMA |
| MORPHINE SULFATE | MORPHINE SULFATE | 30MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078761 | SUN PHARM INDS LTD |
| MS CONTIN | MORPHINE SULFATE | 30MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 019516 | PURDUE PHARMA LP |
TABLET, EXTENDED RELEASE;ORAL; 60MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MORPHINE SULFATE | MORPHINE SULFATE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203849 | ACTAVIS ELIZABETH |
| MORPHINE SULFATE | MORPHINE SULFATE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203602 | NOVEL LABS INC |
| MORPHINE SULFATE | MORPHINE SULFATE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 074862 | RHODES PHARMS |
| MORPHINE SULFATE | MORPHINE SULFATE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 076412 | SPECGX LLC |
| MORPHINE SULFATE | MORPHINE SULFATE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 075295 | STRIDES PHARMA |
| MORPHINE SULFATE | MORPHINE SULFATE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078761 | SUN PHARM INDS LTD |
| MS CONTIN | MORPHINE SULFATE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 019516 | PURDUE PHARMA LP |
TABLET, EXTENDED RELEASE;ORAL; 15MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MORPHINE SULFATE | MORPHINE SULFATE | 15MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203849 | ACTAVIS ELIZABETH |
| MORPHINE SULFATE | MORPHINE SULFATE | 15MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 075407 | DAVA PHARMS INC |
| MORPHINE SULFATE | MORPHINE SULFATE | 15MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203602 | NOVEL LABS INC |
| MORPHINE SULFATE | MORPHINE SULFATE | 15MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 074862 | RHODES PHARMS |
| MORPHINE SULFATE | MORPHINE SULFATE | 15MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 076412 | SPECGX LLC |
| MORPHINE SULFATE | MORPHINE SULFATE | 15MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 075295 | STRIDES PHARMA |
| MORPHINE SULFATE | MORPHINE SULFATE | 15MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078761 | SUN PHARM INDS LTD |
| MS CONTIN | MORPHINE SULFATE | 15MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 019516 | PURDUE PHARMA LP |
TABLET, EXTENDED RELEASE;ORAL; 100MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MORPHINE SULFATE | MORPHINE SULFATE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203849 | ACTAVIS ELIZABETH |
| MORPHINE SULFATE | MORPHINE SULFATE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203602 | NOVEL LABS INC |
| MORPHINE SULFATE | MORPHINE SULFATE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 074769 | RHODES PHARMS |
| MORPHINE SULFATE | MORPHINE SULFATE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 076438 | SPECGX LLC |
| MORPHINE SULFATE | MORPHINE SULFATE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 075295 | STRIDES PHARMA |
| MORPHINE SULFATE | MORPHINE SULFATE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078761 | SUN PHARM INDS LTD |
| MS CONTIN | MORPHINE SULFATE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 019516 | PURDUE PHARMA LP |
TABLET, EXTENDED RELEASE;ORAL; 200MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MORPHINE SULFATE | MORPHINE SULFATE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203849 | ACTAVIS ELIZABETH |
| MORPHINE SULFATE | MORPHINE SULFATE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203602 | NOVEL LABS INC |
| MORPHINE SULFATE | MORPHINE SULFATE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 074769 | RHODES PHARMS |
| MORPHINE SULFATE | MORPHINE SULFATE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 076438 | SPECGX LLC |
| MORPHINE SULFATE | MORPHINE SULFATE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 075295 | STRIDES PHARMA |
| MORPHINE SULFATE | MORPHINE SULFATE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078761 | SUN PHARM INDS LTD |
| MS CONTIN | MORPHINE SULFATE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 019516 | PURDUE PHARMA LP |