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
BRIXADI از شرکت BRAEBURN PHARMA INC
New Drug Application (NDA): 210136
Company: BRAEBURN PHARMA INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BRIXADI | BUPRENORPHINE | 8MG | INJECTION, EXTENDED RELEASE;SUBCUTANEOUS | None (Tentative Approval) |
None |
No | No |
| BRIXADI | BUPRENORPHINE | 16MG | INJECTION, EXTENDED RELEASE;SUBCUTANEOUS | None (Tentative Approval) |
None |
No | No |
| BRIXADI | BUPRENORPHINE | 24MG | INJECTION, EXTENDED RELEASE;SUBCUTANEOUS | None (Tentative Approval) |
None |
No | No |
| BRIXADI | BUPRENORPHINE | 32MG | INJECTION, EXTENDED RELEASE;SUBCUTANEOUS | None (Tentative Approval) |
None |
No | No |
| BRIXADI | BUPRENORPHINE | 64MG | INJECTION, EXTENDED RELEASE;SUBCUTANEOUS | None (Tentative Approval) |
None |
No | No |
| BRIXADI | BUPRENORPHINE | 96MG | INJECTION, EXTENDED RELEASE;SUBCUTANEOUS | None (Tentative Approval) |
None |
No | No |
| BRIXADI | BUPRENORPHINE | 128MG | INJECTION, EXTENDED RELEASE;SUBCUTANEOUS | None (Tentative Approval) |
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 |
|---|---|---|---|---|---|---|---|
| 12/21/2018 | ORIG-1 | Tentative Approval |
Type 3 – New Dosage Form and Type 4 – New Combination |
PRIORITY |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210136Orig1s000TALtr.pdf |
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