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 AM REGENT
Abbreviated New Drug Application (ANDA): 078331
Company: AM REGENT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | EQ 0.3MG BASE/ML | INJECTABLE;INJECTION | Prescription |
AP |
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 |
|---|---|---|---|---|---|---|---|
| 03/27/2007 | ORIG-1 | Approval |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/23/2020 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/23/2020 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
BUPRENORPHINE HYDROCHLORIDE
INJECTABLE;INJECTION; EQ 0.3MG BASE/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BUPRENEX | BUPRENORPHINE HYDROCHLORIDE | EQ 0.3MG BASE/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 018401 | INDIVIOR INC |
| BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | EQ 0.3MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 078331 | AM REGENT |
| BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | EQ 0.3MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 074137 | HOSPIRA |
| BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | EQ 0.3MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 206586 | PAR STERILE PRODUCTS |
| BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | EQ 0.3MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 076931 | WEST-WARD PHARMS INT |
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