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
BUPRENORPHINE HYDROCHLORIDE از شرکت MYLAN
Abbreviated New Drug Application (ANDA): 201066
Company: MYLAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | EQ 2MG BASE | TABLET;SUBLINGUAL | Discontinued |
None |
No | No |
| BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | EQ 8MG BASE | TABLET;SUBLINGUAL | Discontinued |
None |
No | 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 |
|---|---|---|---|---|---|---|---|
| 03/06/2015 | ORIG-1 | Approval |
Not Applicable |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/04/2021 | SUPPL-13 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/07/2019 | SUPPL-11 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/31/2018 | SUPPL-9 | REMS – MODIFIED – D-N-A |
Label is not available on this site. |
||
| 02/01/2018 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/31/2018 | SUPPL-7 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 01/31/2018 | SUPPL-6 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/23/2017 | SUPPL-5 | REMS-Modified |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-3 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 07/07/2016 | SUPPL-2 | REMS-Proposal |
Label is not available on this site. |
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