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 |
|---|
| 2016/11/04 |
ORIG-1（原始申请） |
Approval |
Not Applicable |
|
|
|
>>>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-20（补充） |
Approval |
REMS - MODIFIED - D-N-A |
|
|
|
| 2023/12/15 |
SUPPL-17（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2023/12/11 |
SUPPL-10（补充） |
Approval |
Labeling-Package Insert,Labeling-Medication Guide |
STANDARD
|
|
|
| 2023/12/11 |
SUPPL-9（补充） |
Approval |
Labeling-Package Insert,Labeling-Medication Guide |
STANDARD
|
|
|
| 2023/12/11 |
SUPPL-6（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2023/12/11 |
SUPPL-2（补充） |
Approval |
Labeling-Medication Guide,Labeling-Package Insert |
STANDARD
|
|
|
| 2018/09/18 |
SUPPL-4（补充） |
Approval |
REMS - MODIFIED - D-N-A |
|
|
|
| 2017/05/26 |
SUPPL-1（补充） |
Approval |
REMS-Modified |
|
|
|
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:FENTANYL; 剂型/给药途径:FILM, EXTENDED RELEASE;TRANSDERMAL; 规格:12.5MCG/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 |
|---|
| 076258 |
005 |
ANDA |
FENTANYL-12 |
FENTANYL |
FILM, EXTENDED RELEASE;TRANSDERMAL |
12.5MCG/HR |
Prescription |
No |
No |
AB |
2007/01/23
|
MYLAN TECHNOLOGIES |
| 077154 |
005 |
ANDA |
FENTANYL-12 |
FENTANYL |
FILM, EXTENDED RELEASE;TRANSDERMAL |
12.5MCG/HR |
Prescription |
No |
No |
AB |
2015/06/11
|
SPECGX LLC |
| 077449 |
005 |
ANDA |
FENTANYL-12 |
FENTANYL |
FILM, EXTENDED RELEASE;TRANSDERMAL |
12.5MCG/HR |
Prescription |
No |
No |
AB |
2015/09/11
|
DIFGEN PHARMS |
| 202097 |
001 |
ANDA |
FENTANYL-12 |
FENTANYL |
FILM, EXTENDED RELEASE;TRANSDERMAL |
12.5MCG/HR |
Prescription |
No |
No |
AB |
2016/11/04
|
KINDEVA |
| 209655 |
001 |
ANDA |
FENTANYL-12 |
FENTANYL |
FILM, EXTENDED RELEASE;TRANSDERMAL |
12.5MCG/HR |
Discontinued |
No |
No |
AB |
2023/01/24
|
ZYDUS PHARMS |
>>>活性成分:FENTANYL; 剂型/给药途径:FILM, EXTENDED RELEASE;TRANSDERMAL; 规格:25MCG/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 |
|---|
| 076258 |
001 |
ANDA |
FENTANYL-25 |
FENTANYL |
FILM, EXTENDED RELEASE;TRANSDERMAL |
25MCG/HR |
Prescription |
No |
No |
AB |
2005/01/28
|
MYLAN TECHNOLOGIES |
| 077449 |
001 |
ANDA |
FENTANYL-25 |
FENTANYL |
FILM, EXTENDED RELEASE;TRANSDERMAL |
25MCG/HR |
Prescription |
No |
No |
AB |
2008/10/20
|
DIFGEN PHARMS |
| 077154 |
001 |
ANDA |
FENTANYL-25 |
FENTANYL |
FILM, EXTENDED RELEASE;TRANSDERMAL |
25MCG/HR |
Prescription |
No |
Yes |
AB |
2011/02/09
|
SPECGX LLC |
| 202097 |
002 |
ANDA |
FENTANYL-25 |
FENTANYL |
FILM, EXTENDED RELEASE;TRANSDERMAL |
25MCG/HR |
Prescription |
No |
No |
AB |
2016/11/04
|
KINDEVA |
| 209655 |
002 |
ANDA |
FENTANYL-25 |
FENTANYL |
FILM, EXTENDED RELEASE;TRANSDERMAL |
25MCG/HR |
Discontinued |
No |
No |
AB |
2023/01/24
|
ZYDUS PHARMS |
>>>活性成分:FENTANYL; 剂型/给药途径:FILM, EXTENDED RELEASE;TRANSDERMAL; 规格:50MCG/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 |
|---|
| 076258 |
002 |
ANDA |
FENTANYL-50 |
FENTANYL |
FILM, EXTENDED RELEASE;TRANSDERMAL |
50MCG/HR |
Prescription |
No |
No |
AB |
2005/01/28
|
MYLAN TECHNOLOGIES |
| 077449 |
002 |
ANDA |
FENTANYL-50 |
FENTANYL |
FILM, EXTENDED RELEASE;TRANSDERMAL |
50MCG/HR |
Prescription |
No |
No |
AB |
2008/10/20
|
DIFGEN PHARMS |
| 077154 |
002 |
ANDA |
FENTANYL-50 |
FENTANYL |
FILM, EXTENDED RELEASE;TRANSDERMAL |
50MCG/HR |
Prescription |
No |
No |
AB |
2011/02/09
|
SPECGX LLC |
| 202097 |
003 |
ANDA |
FENTANYL-50 |
FENTANYL |
FILM, EXTENDED RELEASE;TRANSDERMAL |
50MCG/HR |
Prescription |
No |
No |
AB |
2016/11/04
|
KINDEVA |
| 209655 |
004 |
ANDA |
FENTANYL-50 |
FENTANYL |
FILM, EXTENDED RELEASE;TRANSDERMAL |
50MCG/HR |
Discontinued |
No |
No |
AB |
2023/01/24
|
ZYDUS PHARMS |
>>>活性成分:FENTANYL; 剂型/给药途径:FILM, EXTENDED RELEASE;TRANSDERMAL; 规格:75MCG/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 |
|---|
| 076258 |
003 |
ANDA |
FENTANYL-75 |
FENTANYL |
FILM, EXTENDED RELEASE;TRANSDERMAL |
75MCG/HR |
Prescription |
No |
No |
AB |
2005/01/28
|
MYLAN TECHNOLOGIES |
| 077449 |
003 |
ANDA |
FENTANYL-75 |
FENTANYL |
FILM, EXTENDED RELEASE;TRANSDERMAL |
75MCG/HR |
Prescription |
No |
No |
AB |
2008/10/20
|
DIFGEN PHARMS |
| 077154 |
003 |
ANDA |
FENTANYL-75 |
FENTANYL |
FILM, EXTENDED RELEASE;TRANSDERMAL |
75MCG/HR |
Prescription |
No |
No |
AB |
2011/02/09
|
SPECGX LLC |
| 202097 |
004 |
ANDA |
FENTANYL-75 |
FENTANYL |
FILM, EXTENDED RELEASE;TRANSDERMAL |
75MCG/HR |
Prescription |
No |
No |
AB |
2016/11/04
|
KINDEVA |
| 209655 |
006 |
ANDA |
FENTANYL-75 |
FENTANYL |
FILM, EXTENDED RELEASE;TRANSDERMAL |
75MCG/HR |
Discontinued |
No |
No |
AB |
2023/01/24
|
ZYDUS PHARMS |
>>>活性成分:FENTANYL; 剂型/给药途径:FILM, EXTENDED RELEASE;TRANSDERMAL; 规格:100MCG/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 |
|---|
| 076258 |
004 |
ANDA |
FENTANYL-100 |
FENTANYL |
FILM, EXTENDED RELEASE;TRANSDERMAL |
100MCG/HR |
Prescription |
No |
No |
AB |
2005/01/28
|
MYLAN TECHNOLOGIES |
| 077449 |
004 |
ANDA |
FENTANYL-100 |
FENTANYL |
FILM, EXTENDED RELEASE;TRANSDERMAL |
100MCG/HR |
Prescription |
No |
No |
AB |
2008/10/20
|
DIFGEN PHARMS |
| 077154 |
004 |
ANDA |
FENTANYL-100 |
FENTANYL |
FILM, EXTENDED RELEASE;TRANSDERMAL |
100MCG/HR |
Prescription |
No |
No |
AB |
2011/02/09
|
SPECGX LLC |
| 202097 |
005 |
ANDA |
FENTANYL-100 |
FENTANYL |
FILM, EXTENDED RELEASE;TRANSDERMAL |
100MCG/HR |
Prescription |
No |
No |
AB |
2016/11/04
|
KINDEVA |
| 209655 |
008 |
ANDA |
FENTANYL-100 |
FENTANYL |
FILM, EXTENDED RELEASE;TRANSDERMAL |
100MCG/HR |
Discontinued |
No |
No |
AB |
2023/01/24
|
ZYDUS PHARMS |