Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019516
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
09/18/2018 SUPPL-54 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019516s053s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019516s053s054lbl.pdf#page=28 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-Package Insert, Labeling-Medication Guide 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
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-54 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019516s053s054lbl.pdf#page=28
09/18/2018 SUPPL-54 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019516s053s054lbl.pdf#page=28
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-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019516s042lbl.pdf
04/16/2014 SUPPL-42 Labeling-Medication Guide 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 205386 MAYNE PHARMA INC
MORPHINE SULFATE MORPHINE SULFATE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 200824 MYLAN PHARMS INC
MORPHINE SULFATE MORPHINE SULFATE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 076720 NESHER PHARMS
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 078761 SUN PHARM INDS LTD
MORPHINE SULFATE MORPHINE SULFATE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205634 SUN PHARM INDUSTRIES
MORPHINE SULFATE MORPHINE SULFATE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 075295 VINTAGE PHARMS LLC
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 205386 MAYNE PHARMA INC
MORPHINE SULFATE MORPHINE SULFATE 60MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 200824 MYLAN PHARMS INC
MORPHINE SULFATE MORPHINE SULFATE 60MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 076720 NESHER PHARMS
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 078761 SUN PHARM INDS LTD
MORPHINE SULFATE MORPHINE SULFATE 60MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205634 SUN PHARM INDUSTRIES
MORPHINE SULFATE MORPHINE SULFATE 60MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 075295 VINTAGE PHARMS LLC
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 205386 MAYNE PHARMA INC
MORPHINE SULFATE MORPHINE SULFATE 15MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 200824 MYLAN PHARMS INC
MORPHINE SULFATE MORPHINE SULFATE 15MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 076733 NESHER PHARMS
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 078761 SUN PHARM INDS LTD
MORPHINE SULFATE MORPHINE SULFATE 15MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205634 SUN PHARM INDUSTRIES
MORPHINE SULFATE MORPHINE SULFATE 15MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 075295 VINTAGE PHARMS LLC
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 205386 MAYNE PHARMA INC
MORPHINE SULFATE MORPHINE SULFATE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 200824 MYLAN PHARMS INC
MORPHINE SULFATE MORPHINE SULFATE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 077855 NESHER PHARMS
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 078761 SUN PHARM INDS LTD
MORPHINE SULFATE MORPHINE SULFATE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205634 SUN PHARM INDUSTRIES
MORPHINE SULFATE MORPHINE SULFATE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 075295 VINTAGE PHARMS LLC
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 077855 NESHER PHARMS
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 078761 SUN PHARM INDS LTD
MORPHINE SULFATE MORPHINE SULFATE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205634 SUN PHARM INDUSTRIES
MORPHINE SULFATE MORPHINE SULFATE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 075295 VINTAGE PHARMS LLC
MS CONTIN MORPHINE SULFATE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 019516 PURDUE PHARMA LP

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