Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 202788
Company: BTCP PHARMA
Company: BTCP PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SUBSYS | FENTANYL | 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY;SUBLINGUAL | Discontinued | None | Yes | No |
| SUBSYS | FENTANYL | 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY;SUBLINGUAL | Discontinued | None | Yes | No |
| SUBSYS | FENTANYL | 0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY;SUBLINGUAL | Discontinued | None | Yes | No |
| SUBSYS | FENTANYL | 0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY;SUBLINGUAL | Discontinued | None | Yes | No |
| SUBSYS | FENTANYL | 0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY;SUBLINGUAL | Discontinued | None | Yes | No |
| SUBSYS | FENTANYL | 1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY;SUBLINGUAL | Discontinued | None | Yes | No |
| SUBSYS | FENTANYL | 1.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY;SUBLINGUAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 01/04/2012 | 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/2012/202788s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202788s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202788_subsys_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202788Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/08/2022 | SUPPL-30 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/202788Orig1s030ltr.pdf |
| 08/17/2022 | SUPPL-29 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/202788Orig1s029ltr.pdf |
| 12/03/2021 | SUPPL-28 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/202788Orig1s028Correctedltr.pdf |
| 03/04/2021 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202788s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/202788Orig1s023ltr.pdf | |
| 12/23/2020 | SUPPL-21 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/202788Orig1s021ltr.pdf |
| 10/07/2019 | SUPPL-20 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202788s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/202788Orig1s020ltr.pdf | |
| 09/07/2017 | SUPPL-18 | REMS-Proposal |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202788Orig1s018ltr.pdf |
| 11/09/2016 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-16 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202788s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202788Orig1s016ltr.pdf | |
| 02/12/2016 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/09/2015 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/24/2014 | SUPPL-12 | REMS-Modified |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202788s009s011s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202788Orig1s009,s011,012ltr.pdf | |
| 12/24/2014 | SUPPL-11 | Manufacturing (CMC) |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202788s009s011s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202788Orig1s009,s011,012ltr.pdf | |
| 11/07/2013 | SUPPL-10 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202788Orig1s010ltr.pdf |
| 12/24/2014 | SUPPL-9 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202788s009s011s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202788Orig1s009,s011,012ltr.pdf | |
| 07/31/2013 | SUPPL-6 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202788s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202788Orig1s005,s006ltr.pdf | |
| 07/31/2013 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202788s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202788Orig1s005,s006ltr.pdf | |
| 06/05/2012 | SUPPL-3 | REMS-Modified |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202788s001s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202788s001,s003ltr.pdf | |
| 08/30/2012 | SUPPL-2 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202788s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202788Orig1s002ltr.pdf | |
| 06/05/2012 | SUPPL-1 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202788s001s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202788s001,s003ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/04/2021 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202788s023lbl.pdf | |
| 10/07/2019 | SUPPL-20 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202788s020lbl.pdf | |
| 10/07/2019 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202788s020lbl.pdf | |
| 12/16/2016 | SUPPL-16 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202788s016lbl.pdf | |
| 12/16/2016 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202788s016lbl.pdf | |
| 12/24/2014 | SUPPL-12 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202788s009s011s012lbl.pdf | |
| 12/24/2014 | SUPPL-11 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202788s009s011s012lbl.pdf |
| 12/24/2014 | SUPPL-9 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202788s009s011s012lbl.pdf | |
| 12/24/2014 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202788s009s011s012lbl.pdf | |
| 07/31/2013 | SUPPL-6 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202788s005s006lbl.pdf | |
| 07/31/2013 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202788s005s006lbl.pdf | |
| 08/30/2012 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202788s002lbl.pdf | |
| 06/05/2012 | SUPPL-3 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202788s001s003lbl.pdf | |
| 06/05/2012 | SUPPL-1 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202788s001s003lbl.pdf | |
| 01/04/2012 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202788s000lbl.pdf |