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
>>>原始批准或临时批准<<<
| 审批日期 | 提交号 | 审批结论 | 提交分类 | 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 |
|---|
| 2022/05/17 |
ORIG-1（原始申请） |
Approval |
|
STANDARD
|
|
|
>>>补充申请<<<
| 审批日期 | 提交号 | 审批结论 | 补充类别或审批类型 | 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 |
|---|
| 2024/10/31 |
SUPPL-6（补充） |
Approval |
REMS - MODIFIED - D-N-A |
|
|
|
| 2022/11/22 |
SUPPL-1（补充） |
Approval |
Labeling-Medication Guide,Labeling-Package Insert |
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; 剂型/给药途径:FILM, EXTENDED RELEASE;TRANSDERMAL; 规格:5MCG/HR; 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 |
|---|
| 021306 |
001 |
NDA |
BUTRANS |
BUPRENORPHINE |
FILM, EXTENDED RELEASE;TRANSDERMAL |
5MCG/HR |
Prescription |
Yes |
No |
AB |
2010/06/30
|
PURDUE PHARMA LP |
| 204937 |
001 |
ANDA |
BUPRENORPHINE |
BUPRENORPHINE |
FILM, EXTENDED RELEASE;TRANSDERMAL |
5MCG/HR |
Prescription |
No |
No |
AB |
2018/11/20
|
WATSON LABS TEVA |
| 211586 |
001 |
ANDA |
BUPRENORPHINE |
BUPRENORPHINE |
FILM, EXTENDED RELEASE;TRANSDERMAL |
5MCG/HR |
Prescription |
No |
No |
AB |
2020/04/14
|
AMNEAL |
| 210272 |
001 |
ANDA |
BUPRENORPHINE |
BUPRENORPHINE |
FILM, EXTENDED RELEASE;TRANSDERMAL |
5MCG/HR |
Prescription |
No |
No |
AB |
2021/09/23
|
DIFGEN PHARMS |
| 207490 |
001 |
ANDA |
BUPRENORPHINE |
BUPRENORPHINE |
FILM, EXTENDED RELEASE;TRANSDERMAL |
5MCG/HR |
Prescription |
No |
No |
AB |
2022/05/17
|
STRIDES PHARMA INTL |
>>>活性成分:BUPRENORPHINE; 剂型/给药途径:FILM, EXTENDED RELEASE;TRANSDERMAL; 规格:10MCG/HR; 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 |
|---|
| 021306 |
002 |
NDA |
BUTRANS |
BUPRENORPHINE |
FILM, EXTENDED RELEASE;TRANSDERMAL |
10MCG/HR |
Prescription |
Yes |
No |
AB |
2010/06/30
|
PURDUE PHARMA LP |
| 204937 |
002 |
ANDA |
BUPRENORPHINE |
BUPRENORPHINE |
FILM, EXTENDED RELEASE;TRANSDERMAL |
10MCG/HR |
Prescription |
No |
No |
AB |
2018/11/20
|
WATSON LABS TEVA |
| 211586 |
003 |
ANDA |
BUPRENORPHINE |
BUPRENORPHINE |
FILM, EXTENDED RELEASE;TRANSDERMAL |
10MCG/HR |
Prescription |
No |
No |
AB |
2020/04/14
|
AMNEAL |
| 210272 |
003 |
ANDA |
BUPRENORPHINE |
BUPRENORPHINE |
FILM, EXTENDED RELEASE;TRANSDERMAL |
10MCG/HR |
Prescription |
No |
No |
AB |
2021/09/23
|
DIFGEN PHARMS |
| 207490 |
002 |
ANDA |
BUPRENORPHINE |
BUPRENORPHINE |
FILM, EXTENDED RELEASE;TRANSDERMAL |
10MCG/HR |
Prescription |
No |
No |
AB |
2022/05/17
|
STRIDES PHARMA INTL |
>>>活性成分:BUPRENORPHINE; 剂型/给药途径:FILM, EXTENDED RELEASE;TRANSDERMAL; 规格:15MCG/HR; 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 |
|---|
| 021306 |
004 |
NDA |
BUTRANS |
BUPRENORPHINE |
FILM, EXTENDED RELEASE;TRANSDERMAL |
15MCG/HR |
Prescription |
Yes |
No |
AB |
2013/07/25
|
PURDUE PHARMA LP |
| 204937 |
003 |
ANDA |
BUPRENORPHINE |
BUPRENORPHINE |
FILM, EXTENDED RELEASE;TRANSDERMAL |
15MCG/HR |
Prescription |
No |
No |
AB |
2018/11/20
|
WATSON LABS TEVA |
| 211586 |
004 |
ANDA |
BUPRENORPHINE |
BUPRENORPHINE |
FILM, EXTENDED RELEASE;TRANSDERMAL |
15MCG/HR |
Prescription |
No |
No |
AB |
2020/04/14
|
AMNEAL |
| 210272 |
004 |
ANDA |
BUPRENORPHINE |
BUPRENORPHINE |
FILM, EXTENDED RELEASE;TRANSDERMAL |
15MCG/HR |
Prescription |
No |
No |
AB |
2021/09/23
|
DIFGEN PHARMS |
| 207490 |
003 |
ANDA |
BUPRENORPHINE |
BUPRENORPHINE |
FILM, EXTENDED RELEASE;TRANSDERMAL |
15MCG/HR |
Prescription |
No |
No |
AB |
2022/05/17
|
STRIDES PHARMA INTL |
>>>活性成分:BUPRENORPHINE; 剂型/给药途径:FILM, EXTENDED RELEASE;TRANSDERMAL; 规格:20MCG/HR; 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 |
|---|
| 021306 |
003 |
NDA |
BUTRANS |
BUPRENORPHINE |
FILM, EXTENDED RELEASE;TRANSDERMAL |
20MCG/HR |
Prescription |
Yes |
Yes |
AB |
2010/06/30
|
PURDUE PHARMA LP |
| 204937 |
004 |
ANDA |
BUPRENORPHINE |
BUPRENORPHINE |
FILM, EXTENDED RELEASE;TRANSDERMAL |
20MCG/HR |
Prescription |
No |
No |
AB |
2018/11/20
|
WATSON LABS TEVA |
| 211586 |
005 |
ANDA |
BUPRENORPHINE |
BUPRENORPHINE |
FILM, EXTENDED RELEASE;TRANSDERMAL |
20MCG/HR |
Prescription |
No |
No |
AB |
2020/04/14
|
AMNEAL |
| 210272 |
005 |
ANDA |
BUPRENORPHINE |
BUPRENORPHINE |
FILM, EXTENDED RELEASE;TRANSDERMAL |
20MCG/HR |
Prescription |
No |
No |
AB |
2021/09/23
|
DIFGEN PHARMS |
| 207490 |
004 |
ANDA |
BUPRENORPHINE |
BUPRENORPHINE |
FILM, EXTENDED RELEASE;TRANSDERMAL |
20MCG/HR |
Prescription |
No |
No |
AB |
2022/05/17
|
STRIDES PHARMA INTL |
>>>活性成分:BUPRENORPHINE; 剂型/给药途径:FILM, EXTENDED RELEASE;TRANSDERMAL; 规格:7.5MCG/HR; 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 |
|---|
| 021306 |
005 |
NDA |
BUTRANS |
BUPRENORPHINE |
FILM, EXTENDED RELEASE;TRANSDERMAL |
7.5MCG/HR |
Prescription |
Yes |
No |
AB |
2014/06/30
|
PURDUE PHARMA LP |
| 211586 |
002 |
ANDA |
BUPRENORPHINE |
BUPRENORPHINE |
FILM, EXTENDED RELEASE;TRANSDERMAL |
7.5MCG/HR |
Prescription |
No |
No |
AB |
2020/04/14
|
AMNEAL |
| 204937 |
005 |
ANDA |
BUPRENORPHINE |
BUPRENORPHINE |
FILM, EXTENDED RELEASE;TRANSDERMAL |
7.5MCG/HR |
Prescription |
No |
No |
AB |
2021/06/29
|
WATSON LABS TEVA |
| 210272 |
002 |
ANDA |
BUPRENORPHINE |
BUPRENORPHINE |
FILM, EXTENDED RELEASE;TRANSDERMAL |
7.5MCG/HR |
Prescription |
No |
No |
AB |
2021/09/23
|
DIFGEN PHARMS |
| 207490 |
005 |
ANDA |
BUPRENORPHINE |
BUPRENORPHINE |
FILM, EXTENDED RELEASE;TRANSDERMAL |
7.5MCG/HR |
Discontinued |
No |
No |
AB |
2023/03/21
|
STRIDES PHARMA INTL |