Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021306
Company: PURDUE PHARMA LP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUTRANS BUPRENORPHINE 5MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription AB Yes No
BUTRANS BUPRENORPHINE 10MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription AB Yes No
BUTRANS BUPRENORPHINE 20MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription AB Yes Yes
BUTRANS BUPRENORPHINE 15MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription AB Yes No
BUTRANS BUPRENORPHINE 7.5MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL 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
06/30/2010 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021306s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021306s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021306_butrans_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021306Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/07/2019 SUPPL-35 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021306s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021306Orig1s035ltr.pdf
09/18/2018 SUPPL-34 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021306s032s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021306Orig1s032s036ltr.pdf
09/18/2018 SUPPL-32 REMS - MODIFIED - D-N-A Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021306s032s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021306Orig1s032s036ltr.pdf
08/14/2017 SUPPL-31 REMS - MODIFIED - D-N-A Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021306Orig1s031ltr.pdf
05/26/2017 SUPPL-30 REMS-Modified Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021306Orig1s030ltr.pdf
10/13/2017 SUPPL-27 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021306s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021306Orig1s027ltr.pdf
09/30/2016 SUPPL-26 REMS - MODIFIED - D-N-A Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021306Orig1s026ltr.pdf
12/16/2016 SUPPL-24 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021306s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021306Orig1s024ltr.pdf
04/20/2016 SUPPL-23 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021306Orig1s023ltr.pdf
06/26/2015 SUPPL-22 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021306Orig1s022ltr.pdf
08/19/2014 SUPPL-20 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021306Orig1s020ltr.pdf
06/30/2014 SUPPL-19 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021306s015s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021306Orig1s015,s019ltr.pdf
04/16/2014 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021306s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021306Orig1s018ltr.pdf
07/25/2013 SUPPL-16 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021306s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021306Orig1s016ltr.pdf
06/30/2014 SUPPL-15 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021306s015s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021306Orig1s015,s019ltr.pdf
03/08/2013 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

04/15/2013 SUPPL-12 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021306Orig1s012ltr.pdf
07/09/2012 SUPPL-8 Labeling, REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021306s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021306Orig1s008ltr.pdf
07/01/2011 SUPPL-3 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021306s001s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021306s001,s003ltr.pdf
07/01/2011 SUPPL-1 Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021306s001s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021306s001,s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/07/2019 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021306s035lbl.pdf
09/18/2018 SUPPL-34 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021306s032s034lbl.pdf
09/18/2018 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021306s032s034lbl.pdf
09/18/2018 SUPPL-32 REMS - MODIFIED - D-N-A Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021306s032s034lbl.pdf
10/13/2017 SUPPL-27 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021306s027lbl.pdf
05/26/2017 SUPPL-30 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021306Orig1s030ltr.pdf
12/16/2016 SUPPL-24 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021306s024lbl.pdf
12/16/2016 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021306s024lbl.pdf
06/30/2014 SUPPL-19 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021306s015s019lbl.pdf
06/30/2014 SUPPL-15 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021306s015s019lbl.pdf
06/30/2014 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021306s015s019lbl.pdf
04/16/2014 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021306s018lbl.pdf
07/25/2013 SUPPL-16 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021306s016lbl.pdf
07/09/2012 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021306s008lbl.pdf
07/09/2012 SUPPL-8 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021306s008lbl.pdf
07/01/2011 SUPPL-3 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021306s001s003lbl.pdf
07/01/2011 SUPPL-1 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021306s001s003lbl.pdf
06/30/2010 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021306s000lbl.pdf

BUTRANS

FILM, EXTENDED RELEASE;TRANSDERMAL; 5MCG/HR
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUPRENORPHINE BUPRENORPHINE 5MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 204937 WATSON LABS TEVA
BUTRANS BUPRENORPHINE 5MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription Yes AB 021306 PURDUE PHARMA LP

FILM, EXTENDED RELEASE;TRANSDERMAL; 10MCG/HR
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUPRENORPHINE BUPRENORPHINE 10MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 204937 WATSON LABS TEVA
BUTRANS BUPRENORPHINE 10MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription Yes AB 021306 PURDUE PHARMA LP

FILM, EXTENDED RELEASE;TRANSDERMAL; 20MCG/HR
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUPRENORPHINE BUPRENORPHINE 20MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 204937 WATSON LABS TEVA
BUTRANS BUPRENORPHINE 20MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription Yes AB 021306 PURDUE PHARMA LP

FILM, EXTENDED RELEASE;TRANSDERMAL; 15MCG/HR
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUPRENORPHINE BUPRENORPHINE 15MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 204937 WATSON LABS TEVA
BUTRANS BUPRENORPHINE 15MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription Yes AB 021306 PURDUE PHARMA LP

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