Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021306
Company: PURDUE PHARMA LP
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 | 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 |
|---|---|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|
| 12/15/2023 | SUPPL-41 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021306s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021306Orig1s041ltr.pdf | |
| 06/17/2022 | SUPPL-39 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021306s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021306Orig1s039ltr.pdf | |
| 03/04/2021 | SUPPL-37 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021306s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021306Orig1s037ltr.pdf | |
| 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-Package Insert, Labeling-Medication Guide |
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-Package Insert, Labeling-Container/Carton Labels |
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 | REMS-Modified, Labeling |
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 |
|---|---|---|---|---|---|
| 12/15/2023 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021306s041lbl.pdf | |
| 06/17/2022 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021306s039lbl.pdf | |
| 03/04/2021 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021306s037lbl.pdf | |
| 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-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021306s032s034lbl.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-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-Package Insert | Label (PDF) | 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 | |
| 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 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021306s008lbl.pdf | |
| 07/09/2012 | SUPPL-8 | Labeling | 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 | 207490 | ALVOGEN |
| BUPRENORPHINE | BUPRENORPHINE | 5MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB | 211586 | AMNEAL |
| BUPRENORPHINE | BUPRENORPHINE | 5MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB | 210272 | AVEVA |
| 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 | 207490 | ALVOGEN |
| BUPRENORPHINE | BUPRENORPHINE | 10MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB | 211586 | AMNEAL |
| BUPRENORPHINE | BUPRENORPHINE | 10MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB | 210272 | AVEVA |
| 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 | 207490 | ALVOGEN |
| BUPRENORPHINE | BUPRENORPHINE | 20MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB | 211586 | AMNEAL |
| BUPRENORPHINE | BUPRENORPHINE | 20MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB | 210272 | AVEVA |
| 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 | 207490 | ALVOGEN |
| BUPRENORPHINE | BUPRENORPHINE | 15MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB | 211586 | AMNEAL |
| BUPRENORPHINE | BUPRENORPHINE | 15MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB | 210272 | AVEVA |
| 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 |
FILM, EXTENDED RELEASE;TRANSDERMAL; 7.5MCG/HR
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BUPRENORPHINE | BUPRENORPHINE | 7.5MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB | 211586 | AMNEAL |
| BUPRENORPHINE | BUPRENORPHINE | 7.5MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB | 210272 | AVEVA |
| BUPRENORPHINE | BUPRENORPHINE | 7.5MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB | 204937 | WATSON LABS TEVA |
| BUTRANS | BUPRENORPHINE | 7.5MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | Yes | AB | 021306 | PURDUE PHARMA LP |