Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022272
Company: PURDUE PHARMA LP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OXYCONTIN OXYCODONE HYDROCHLORIDE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription None Yes No
OXYCONTIN OXYCODONE HYDROCHLORIDE 15MG TABLET, EXTENDED RELEASE;ORAL Prescription None Yes No
OXYCONTIN OXYCODONE HYDROCHLORIDE 20MG TABLET, EXTENDED RELEASE;ORAL Prescription None Yes No
OXYCONTIN OXYCODONE HYDROCHLORIDE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription None Yes No
OXYCONTIN OXYCODONE HYDROCHLORIDE 40MG TABLET, EXTENDED RELEASE;ORAL Prescription None Yes Yes
OXYCONTIN OXYCODONE HYDROCHLORIDE 60MG TABLET, EXTENDED RELEASE;ORAL Prescription None Yes No
OXYCONTIN OXYCODONE HYDROCHLORIDE 80MG TABLET, 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
04/05/2010 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer PRIORITY Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022272lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022272s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022272s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022272s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/18/2018 SUPPL-41 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022272s040s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022272Orig1s040s041ltr.pdf
09/18/2018 SUPPL-40 REMS - MODIFIED - D-N-A Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022272s040s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022272Orig1s040s041ltr.pdf
09/26/2018 SUPPL-39 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022272s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022272Orig1s039ltr.pdf
05/26/2017 SUPPL-37 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022272Orig1s037ltr.pdf
09/30/2016 SUPPL-36 REMS - MODIFIED - D-N-A Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022272Orig1s036ltr.pdf
12/16/2016 SUPPL-34 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022272s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022272Orig1s034ltr.pdf
04/20/2016 SUPPL-33 REMS-Modified

Label is not available on this site.

03/28/2016 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

03/25/2016 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

11/12/2015 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

09/10/2015 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

06/26/2015 SUPPL-28 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022272Orig1s028ltr.pdf
08/13/2015 SUPPL-27 Efficacy-Pediatric Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022272s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022272Orig1s027ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/022272Orig1s027TOC.cfm
10/13/2014 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

08/19/2014 SUPPL-24 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022272Orig1s024ltr.pdf
10/22/2014 SUPPL-23 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022272Orig1s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019516Orig1s043,022272Orig1s023ltr.pdf
04/16/2014 SUPPL-22 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022272s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022272Orig1s022ltr.pdf
01/31/2014 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

04/15/2013 SUPPL-17 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022272Orig1s017ltr.pdf
01/11/2013 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022272s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020553Orig1s065,022272Orig1s016ltr.pdf
02/04/2014 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

04/16/2013 SUPPL-14 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022272Orig1s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022272Orig1s014Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022272Orig1s014TOC.cfm
07/09/2012 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022272s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022272Orig1s011ltr.pdf
07/09/2012 SUPPL-10 Labeling, REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022272s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022272Orig1s010ltr.pdf
10/05/2011 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022272s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022272s009ltr.pdf
11/15/2010 SUPPL-6 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022272s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022272s006ltr.pdf
06/29/2010 SUPPL-5 REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022272s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022272s005ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/26/2018 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022272s039lbl.pdf
09/18/2018 SUPPL-41 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022272s040s041lbl.pdf
09/18/2018 SUPPL-40 REMS - MODIFIED - D-N-A Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022272s040s041lbl.pdf
12/16/2016 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022272s034lbl.pdf
08/13/2015 SUPPL-27 Efficacy-Pediatric Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022272s027lbl.pdf
10/22/2014 SUPPL-23 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022272Orig1s023lbl.pdf
04/16/2014 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022272s022lbl.pdf
04/16/2013 SUPPL-14 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022272Orig1s014lbl.pdf
01/11/2013 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022272s016lbl.pdf
07/09/2012 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022272s011lbl.pdf
07/09/2012 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022272s010lbl.pdf
07/09/2012 SUPPL-10 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022272s010lbl.pdf
10/05/2011 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022272s009lbl.pdf
11/15/2010 SUPPL-6 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022272s006lbl.pdf
06/29/2010 SUPPL-5 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022272s005lbl.pdf
04/05/2010 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022272lbl.pdf

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