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
BELBUCA از شرکت BDSI
New Drug Application (NDA): 207932
Company: BDSI
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BELBUCA | BUPRENORPHINE HYDROCHLORIDE | EQ 0.075MG BASE | FILM;BUCCAL | Prescription |
AB |
Yes | No |
| BELBUCA | BUPRENORPHINE HYDROCHLORIDE | EQ 0.15MG BASE | FILM;BUCCAL | Prescription |
AB |
Yes | No |
| BELBUCA | BUPRENORPHINE HYDROCHLORIDE | EQ 0.3MG BASE | FILM;BUCCAL | Prescription |
AB |
Yes | No |
| BELBUCA | BUPRENORPHINE HYDROCHLORIDE | EQ 0.45MG BASE | FILM;BUCCAL | Prescription |
AB |
Yes | No |
| BELBUCA | BUPRENORPHINE HYDROCHLORIDE | EQ 0.6MG BASE | FILM;BUCCAL | Prescription |
AB |
Yes | No |
| BELBUCA | BUPRENORPHINE HYDROCHLORIDE | EQ 0.75MG BASE | FILM;BUCCAL | Prescription |
AB |
Yes | No |
| BELBUCA | BUPRENORPHINE HYDROCHLORIDE | EQ 0.9MG BASE | FILM;BUCCAL | Prescription |
AB |
Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 10/23/2015 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207932s000lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/04/2021 | SUPPL-15 | Labeling-Medication Guide, Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207932s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/207932Orig1s015ltr.pdf |
||
| 10/07/2019 | SUPPL-12 | Labeling-Medication Guide, Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207932s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/207932Orig1s012ltr.pdf |
||
| 10/16/2019 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/207932Orig1s010ltr.pdf |
|
| 09/18/2018 | SUPPL-9 | Labeling-Medication Guide, Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207932s008s009lbl.pdf |
||
| 09/18/2018 | SUPPL-8 | REMS – MODIFIED – D-N-A |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207932s008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207932Orig1s008s009ltr.pdf |
||
| 05/26/2017 | SUPPL-6 | REMS-Modified |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207932Orig1s006ltr.pdf |
|
| 09/30/2016 | SUPPL-3 | REMS – MODIFIED – D-N-A |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207932Orig1s003ltr.pdf |
|
| 12/16/2016 | SUPPL-2 | Labeling-Package Insert, Labeling-Medication Guide |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207932s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207932Orig1s002ltr.pdf |
||
| 04/20/2016 | SUPPL-1 | REMS-Modified |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207932Orig1s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/04/2021 | SUPPL-15 |
Labeling-Medication Guide |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207932s015lbl.pdf | |
| 03/04/2021 | SUPPL-15 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207932s015lbl.pdf | |
| 10/07/2019 | SUPPL-12 |
Labeling-Medication Guide |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207932s012lbl.pdf | |
| 10/07/2019 | SUPPL-12 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207932s012lbl.pdf | |
| 09/18/2018 | SUPPL-9 |
Labeling-Medication Guide |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207932s008s009lbl.pdf | |
| 09/18/2018 | SUPPL-9 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207932s008s009lbl.pdf | |
| 09/18/2018 | SUPPL-8 |
REMS – MODIFIED – D-N-A |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207932s008s009lbl.pdf | |
| 12/16/2016 | SUPPL-2 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207932s002lbl.pdf | |
| 12/16/2016 | SUPPL-2 |
Labeling-Medication Guide |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207932s002lbl.pdf | |
| 10/23/2015 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207932s000lbl.pdf |
BELBUCA
FILM;BUCCAL; EQ 0.075MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BELBUCA | BUPRENORPHINE HYDROCHLORIDE | EQ 0.075MG BASE | FILM;BUCCAL | Prescription | Yes | AB | 207932 | BDSI |
| BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | EQ 0.075MG BASE | FILM;BUCCAL | Prescription | No | AB | 211594 | ALVOGEN |
FILM;BUCCAL; EQ 0.15MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BELBUCA | BUPRENORPHINE HYDROCHLORIDE | EQ 0.15MG BASE | FILM;BUCCAL | Prescription | Yes | AB | 207932 | BDSI |
| BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | EQ 0.15MG BASE | FILM;BUCCAL | Prescription | No | AB | 211594 | ALVOGEN |
FILM;BUCCAL; EQ 0.3MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BELBUCA | BUPRENORPHINE HYDROCHLORIDE | EQ 0.3MG BASE | FILM;BUCCAL | Prescription | Yes | AB | 207932 | BDSI |
| BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | EQ 0.3MG BASE | FILM;BUCCAL | Prescription | No | AB | 211594 | ALVOGEN |
FILM;BUCCAL; EQ 0.45MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BELBUCA | BUPRENORPHINE HYDROCHLORIDE | EQ 0.45MG BASE | FILM;BUCCAL | Prescription | Yes | AB | 207932 | BDSI |
| BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | EQ 0.45MG BASE | FILM;BUCCAL | Prescription | No | AB | 211594 | ALVOGEN |
FILM;BUCCAL; EQ 0.6MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BELBUCA | BUPRENORPHINE HYDROCHLORIDE | EQ 0.6MG BASE | FILM;BUCCAL | Prescription | Yes | AB | 207932 | BDSI |
| BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | EQ 0.6MG BASE | FILM;BUCCAL | Prescription | No | AB | 211594 | ALVOGEN |
FILM;BUCCAL; EQ 0.75MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BELBUCA | BUPRENORPHINE HYDROCHLORIDE | EQ 0.75MG BASE | FILM;BUCCAL | Prescription | Yes | AB | 207932 | BDSI |
| BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | EQ 0.75MG BASE | FILM;BUCCAL | Prescription | No | AB | 211594 | ALVOGEN |
FILM;BUCCAL; EQ 0.9MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BELBUCA | BUPRENORPHINE HYDROCHLORIDE | EQ 0.9MG BASE | FILM;BUCCAL | Prescription | Yes | AB | 207932 | BDSI |
| BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | EQ 0.9MG BASE | FILM;BUCCAL | Prescription | No | AB | 211594 | ALVOGEN |
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