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
BUPRENEX از شرکت INDIVIOR INC
New Drug Application (NDA): 018401
Company: INDIVIOR INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUPRENEX | BUPRENORPHINE HYDROCHLORIDE | EQ 0.3MG BASE/ML | INJECTABLE;INJECTION | Prescription |
AP |
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 |
|---|---|---|---|---|---|---|---|
| 12/29/1981 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
STANDARD |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/07/2019 | SUPPL-25 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018401s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/018401Orig1s025ltr.pdf |
||
| 12/16/2016 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018401Orig1s022ltr.pdf |
|
| 05/11/2015 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/08/2013 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/06/2014 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/04/2013 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/10/2003 | SUPPL-15 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18401slr015ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/018401_S015_Buprenex Injectable_APPROVAL PACKAGE.pdf |
|
| 02/11/2002 | SUPPL-14 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18401s014ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/018401_s014_BuprenexTOC.cfm |
|
| 11/29/1995 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/13/1995 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/25/1993 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 04/29/1994 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/05/1989 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/09/1989 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/19/1987 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 02/13/1987 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 05/17/1985 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/19/1982 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/28/1985 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/07/2019 | SUPPL-25 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018401s025lbl.pdf |
BUPRENEX
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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