اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
BUNAVAIL از شرکت BDSI
New Drug Application (NDA): 205637
Company: BDSI
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUNAVAIL | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 2.1MG BASE;EQ 0.3MG BASE | FILM;BUCCAL | Discontinued |
None |
Yes | No |
| BUNAVAIL | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 4.2MG BASE;EQ 0.7MG BASE | FILM;BUCCAL | Discontinued |
None |
Yes | No |
| BUNAVAIL | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 6.3MG BASE;EQ 1MG BASE | FILM;BUCCAL | 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 |
|---|---|---|---|---|---|---|---|
| 06/06/2014 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205637s000lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/04/2021 | SUPPL-21 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205637s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/205637Orig1s021ltr.pdf |
||
| 10/07/2019 | SUPPL-20 | Labeling-Package Insert, Labeling-Medication Guide |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205637s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205637Orig1s020ltr.pdf |
||
| 10/31/2018 | SUPPL-19 | REMS – PROPOSAL – D-N-A |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205637Orig1s019ltr.pdf |
|
| 02/01/2018 | SUPPL-16 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205637s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205637Orig1s016ltr.pdf |
||
| 05/23/2017 | SUPPL-14 | REMS-Modified |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205637Orig1s014ltr.pdf |
|
| 04/27/2017 | SUPPL-13 | Labeling-Medication Guide, Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205637s007s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205637Orig1s007,205637Orig1s013ltr.pdf |
||
| 12/16/2016 | SUPPL-11 | Labeling-Medication Guide, Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205637s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205637Orig1s011ltr.pdf |
||
| 07/07/2016 | SUPPL-9 | REMS-Modified |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205637Orig1s009ltr.pdf |
|
| 04/27/2017 | SUPPL-7 | Labeling-Package Insert, Efficacy-New Dosing Regimen |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205637s007s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205637Orig1s007,205637Orig1s013ltr.pdf |
||
| 10/14/2015 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/12/2015 | SUPPL-4 | REMS-Modified |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205637Orig1s004ltr.pdf |
|
| 04/24/2015 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/25/2018 | SUPPL-1 | Labeling-Container/Carton Labels |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/04/2021 | SUPPL-21 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205637s021lbl.pdf | |
| 10/07/2019 | SUPPL-20 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205637s020lbl.pdf | |
| 10/07/2019 | SUPPL-20 |
Labeling-Medication Guide |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205637s020lbl.pdf | |
| 02/01/2018 | SUPPL-16 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205637s016lbl.pdf | |
| 04/27/2017 | SUPPL-13 |
Labeling-Medication Guide |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205637s007s013lbl.pdf | |
| 04/27/2017 | SUPPL-13 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205637s007s013lbl.pdf | |
| 04/27/2017 | SUPPL-7 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205637s007s013lbl.pdf | |
| 04/27/2017 | SUPPL-7 |
Efficacy-New Dosing Regimen |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205637s007s013lbl.pdf | |
| 12/16/2016 | SUPPL-11 |
Labeling-Medication Guide |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205637s011lbl.pdf | |
| 12/16/2016 | SUPPL-11 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205637s011lbl.pdf | |
| 06/06/2014 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205637s000lbl.pdf |
نظرات کاربران