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 |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 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-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 |