批准日期，申请提交历史，通知信，药品说明书，审评文件等信息
| 提交状态日期 | 提交号 | 审批结论 | 申请内容分类 | 审评优先级；罕用药状态 | 通知信、审评文件、说明书、包装标签 | 备注 |
|---|
| 2024/06/12 |
SUPPL-23（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2024/06/12 |
SUPPL-18（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2024/06/12 |
SUPPL-14（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2024/06/12 |
SUPPL-10（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2024/06/12 |
SUPPL-7（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2024/06/12 |
SUPPL-6（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2024/03/20 |
SUPPL-17（补充） |
Approval |
REMS |
|
|
|
| 2022/12/16 |
SUPPL-15（补充） |
Approval |
REMS |
|
|
|
| 2022/05/03 |
SUPPL-12（补充） |
Approval |
REMS |
|
|
|
| 2018/10/31 |
SUPPL-1（补充） |
Approval |
REMS |
|
|
|
| 2018/06/14 |
ORIG-2（原始申请） |
Approval |
|
STANDARD
|
|
|
| 2018/06/14 |
ORIG-1（原始申请） |
Approval |
|
STANDARD
|
|
|
与本品相关的专利信息（来自FDA橙皮书Orange Book）
| 关联产品号 | 专利号 | 专利过期日 | 是否物质专利 | 是否产品专利 | 专利用途代码 | 撤销请求 | 提交日期 | 专利下载 | 备注 |
|---|
| 无 |
与本品治疗等效的药品
活性成分:BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE 剂型/给药途径:FILM;BUCCAL, SUBLINGUAL 规格:EQ 8MG BASE;EQ 2MG BASE 治疗等效代码:AB
| 申请号 | 产品号 | 申请类型 | 商品名 | 活性成分 | 剂型/给药途径 | 规格 | 市场状态 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
|---|
| 022410 |
002 |
NDA |
SUBOXONE |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
FILM;BUCCAL, SUBLINGUAL |
EQ 8MG BASE;EQ 2MG BASE |
Prescription |
Yes |
No |
AB |
2010/08/30
|
INDIVIOR |
| 205299 |
002 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
FILM;BUCCAL, SUBLINGUAL |
EQ 8MG BASE;EQ 2MG BASE |
Prescription |
No |
No |
AB |
2018/06/14
|
DR REDDYS LABS SA |
| 207607 |
001 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
FILM;BUCCAL, SUBLINGUAL |
EQ 8MG BASE;EQ 2MG BASE |
Prescription |
No |
No |
AB |
2018/06/14
|
MYLAN TECHNOLOGIES |
| 205954 |
003 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
FILM;BUCCAL, SUBLINGUAL |
EQ 8MG BASE;EQ 2MG BASE |
Prescription |
No |
No |
AB |
2019/01/24
|
ALVOGEN |
| 212756 |
001 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
FILM;BUCCAL, SUBLINGUAL |
EQ 8MG BASE;EQ 2MG BASE |
Prescription |
No |
No |
AB |
2022/06/02
|
DIFGEN PHARMS |
活性成分:BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE 剂型/给药途径:FILM;BUCCAL, SUBLINGUAL 规格:EQ 8MG BASE;EQ 2MG BASE 治疗等效代码:AB
| 申请号 | 产品号 | 申请类型 | 商品名 | 活性成分 | 剂型/给药途径 | 规格 | 市场状态 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
|---|
| 022410 |
002 |
NDA |
SUBOXONE |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
FILM;BUCCAL, SUBLINGUAL |
EQ 8MG BASE;EQ 2MG BASE |
Prescription |
Yes |
No |
AB |
2010/08/30
|
INDIVIOR |
| 205299 |
002 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
FILM;BUCCAL, SUBLINGUAL |
EQ 8MG BASE;EQ 2MG BASE |
Prescription |
No |
No |
AB |
2018/06/14
|
DR REDDYS LABS SA |
| 207607 |
001 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
FILM;BUCCAL, SUBLINGUAL |
EQ 8MG BASE;EQ 2MG BASE |
Prescription |
No |
No |
AB |
2018/06/14
|
MYLAN TECHNOLOGIES |
| 205954 |
003 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
FILM;BUCCAL, SUBLINGUAL |
EQ 8MG BASE;EQ 2MG BASE |
Prescription |
No |
No |
AB |
2019/01/24
|
ALVOGEN |
| 212756 |
001 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
FILM;BUCCAL, SUBLINGUAL |
EQ 8MG BASE;EQ 2MG BASE |
Prescription |
No |
No |
AB |
2022/06/02
|
DIFGEN PHARMS |
活性成分:BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE 剂型/给药途径:FILM;BUCCAL, SUBLINGUAL 规格:EQ 12MG BASE;EQ 3MG BASE 治疗等效代码:AB
| 申请号 | 产品号 | 申请类型 | 商品名 | 活性成分 | 剂型/给药途径 | 规格 | 市场状态 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
|---|
| 022410 |
004 |
NDA |
SUBOXONE |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
FILM;BUCCAL, SUBLINGUAL |
EQ 12MG BASE;EQ 3MG BASE |
Prescription |
Yes |
Yes |
AB |
2012/08/10
|
INDIVIOR |
| 205806 |
002 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
FILM;BUCCAL, SUBLINGUAL |
EQ 12MG BASE;EQ 3MG BASE |
Prescription |
No |
No |
AB |
2018/06/14
|
DR REDDYS LABS SA |
| 207607 |
002 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
FILM;BUCCAL, SUBLINGUAL |
EQ 12MG BASE;EQ 3MG BASE |
Prescription |
No |
No |
AB |
2018/06/14
|
MYLAN TECHNOLOGIES |
| 205954 |
004 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
FILM;BUCCAL, SUBLINGUAL |
EQ 12MG BASE;EQ 3MG BASE |
Prescription |
No |
No |
AB |
2019/01/24
|
ALVOGEN |
| 212756 |
002 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
FILM;BUCCAL, SUBLINGUAL |
EQ 12MG BASE;EQ 3MG BASE |
Prescription |
No |
No |
AB |
2022/06/02
|
DIFGEN PHARMS |
活性成分:BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE 剂型/给药途径:FILM;BUCCAL, SUBLINGUAL 规格:EQ 12MG BASE;EQ 3MG BASE 治疗等效代码:AB
| 申请号 | 产品号 | 申请类型 | 商品名 | 活性成分 | 剂型/给药途径 | 规格 | 市场状态 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
|---|
| 022410 |
004 |
NDA |
SUBOXONE |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
FILM;BUCCAL, SUBLINGUAL |
EQ 12MG BASE;EQ 3MG BASE |
Prescription |
Yes |
Yes |
AB |
2012/08/10
|
INDIVIOR |
| 205806 |
002 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
FILM;BUCCAL, SUBLINGUAL |
EQ 12MG BASE;EQ 3MG BASE |
Prescription |
No |
No |
AB |
2018/06/14
|
DR REDDYS LABS SA |
| 207607 |
002 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
FILM;BUCCAL, SUBLINGUAL |
EQ 12MG BASE;EQ 3MG BASE |
Prescription |
No |
No |
AB |
2018/06/14
|
MYLAN TECHNOLOGIES |
| 205954 |
004 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
FILM;BUCCAL, SUBLINGUAL |
EQ 12MG BASE;EQ 3MG BASE |
Prescription |
No |
No |
AB |
2019/01/24
|
ALVOGEN |
| 212756 |
002 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
FILM;BUCCAL, SUBLINGUAL |
EQ 12MG BASE;EQ 3MG BASE |
Prescription |
No |
No |
AB |
2022/06/02
|
DIFGEN PHARMS |
