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 |
|---|
| 2021/12/13 |
SUPPL-38（补充） |
Approval |
Manufacturing (CMC) |
N/A
|
|
|
| 2019/01/16 |
SUPPL-37（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2016/12/22 |
SUPPL-33（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2016/09/30 |
SUPPL-32（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2016/06/07 |
SUPPL-29（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 2014/11/19 |
SUPPL-31（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2014/06/05 |
SUPPL-30（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 2013/11/19 |
SUPPL-28（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2013/09/05 |
SUPPL-27（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 2013/03/06 |
SUPPL-26（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 2013/01/10 |
SUPPL-25（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 2011/11/13 |
SUPPL-24（补充） |
Approval |
Labeling |
UNKNOWN
|
|
|
| 2011/03/25 |
SUPPL-21（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2003/05/08 |
SUPPL-20（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 2003/01/17 |
SUPPL-19（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 2002/12/10 |
SUPPL-18（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 2002/11/21 |
SUPPL-17（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 2002/03/06 |
SUPPL-16（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2002/03/06 |
SUPPL-14（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2001/05/03 |
SUPPL-15（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 2000/03/03 |
SUPPL-6（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 1999/05/05 |
SUPPL-12（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 1998/08/21 |
SUPPL-9（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 1998/08/21 |
SUPPL-8（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 1998/06/23 |
SUPPL-7（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 1996/11/07 |
SUPPL-5（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 1996/06/14 |
SUPPL-4（补充） |
Approval |
Efficacy |
STANDARD
|
|
|
| 1994/05/20 |
SUPPL-2（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 1992/06/17 |
ORIG-1（原始申请） |
Approval |
Type 3 - New Dosage Form |
PRIORITY
;Orphan
|
|
|
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:BACLOFEN 剂型/给药途径:INJECTABLE;INTRATHECAL 规格:0.5MG/ML 治疗等效代码:AP
| 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 |
|---|
| 020075 |
001 |
NDA |
LIORESAL |
BACLOFEN |
INJECTABLE;INTRATHECAL |
0.5MG/ML |
Prescription |
Yes |
Yes |
AP |
1992/06/17
|
AMNEAL |
| 022462 |
002 |
NDA |
GABLOFEN |
BACLOFEN |
INJECTABLE;INTRATHECAL |
0.5MG/ML |
Prescription |
Yes |
Yes |
AP |
2010/11/19
|
PIRAMAL CRITICAL |
| 091193 |
002 |
ANDA |
BACLOFEN |
BACLOFEN |
INJECTABLE;INTRATHECAL |
0.5MG/ML |
Prescription |
No |
No |
AP |
2016/05/03
|
AMNEAL |
| 209592 |
001 |
ANDA |
BACLOFEN |
BACLOFEN |
INJECTABLE;INTRATHECAL |
0.5MG/ML |
Prescription |
No |
No |
AP |
2018/03/21
|
MYLAN LABS LTD |
| 210048 |
001 |
ANDA |
BACLOFEN |
BACLOFEN |
INJECTABLE;INTRATHECAL |
0.5MG/ML |
Prescription |
No |
No |
AP |
2019/09/11
|
MAIA PHARMS INC |
| 217324 |
001 |
ANDA |
BACLOFEN |
BACLOFEN |
INJECTABLE;INTRATHECAL |
0.5MG/ML |
Prescription |
No |
No |
AP |
2023/02/22
|
RUBICON |
| 216309 |
001 |
ANDA |
BACLOFEN |
BACLOFEN |
INJECTABLE;INTRATHECAL |
0.5MG/ML |
Discontinued |
No |
No |
AP |
2023/08/10
|
HERITAGE |
活性成分:BACLOFEN 剂型/给药途径:INJECTABLE;INTRATHECAL 规格:2MG/ML 治疗等效代码:AP
| 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 |
|---|
| 020075 |
002 |
NDA |
LIORESAL |
BACLOFEN |
INJECTABLE;INTRATHECAL |
2MG/ML |
Prescription |
Yes |
Yes |
AP |
1992/06/17
|
AMNEAL |
| 022462 |
003 |
NDA |
GABLOFEN |
BACLOFEN |
INJECTABLE;INTRATHECAL |
2MG/ML |
Prescription |
Yes |
Yes |
AP |
2010/11/19
|
PIRAMAL CRITICAL |
| 091193 |
003 |
ANDA |
BACLOFEN |
BACLOFEN |
INJECTABLE;INTRATHECAL |
2MG/ML |
Prescription |
No |
No |
AP |
2016/05/03
|
AMNEAL |
| 209592 |
002 |
ANDA |
BACLOFEN |
BACLOFEN |
INJECTABLE;INTRATHECAL |
2MG/ML |
Prescription |
No |
No |
AP |
2018/03/21
|
MYLAN LABS LTD |
| 210048 |
002 |
ANDA |
BACLOFEN |
BACLOFEN |
INJECTABLE;INTRATHECAL |
2MG/ML |
Prescription |
No |
No |
AP |
2019/09/11
|
MAIA PHARMS INC |
| 217324 |
003 |
ANDA |
BACLOFEN |
BACLOFEN |
INJECTABLE;INTRATHECAL |
2MG/ML |
Prescription |
No |
No |
AP |
2023/02/22
|
RUBICON |
| 216309 |
002 |
ANDA |
BACLOFEN |
BACLOFEN |
INJECTABLE;INTRATHECAL |
2MG/ML |
Discontinued |
No |
No |
AP |
2023/08/10
|
HERITAGE |
活性成分:BACLOFEN 剂型/给药途径:INJECTABLE;INTRATHECAL 规格:0.05MG/ML 治疗等效代码:AP
| 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 |
|---|
| 020075 |
003 |
NDA |
LIORESAL |
BACLOFEN |
INJECTABLE;INTRATHECAL |
0.05MG/ML |
Prescription |
Yes |
Yes |
AP |
1996/11/07
|
AMNEAL |
| 022462 |
001 |
NDA |
GABLOFEN |
BACLOFEN |
INJECTABLE;INTRATHECAL |
0.05MG/ML |
Prescription |
Yes |
Yes |
AP |
2010/11/19
|
PIRAMAL CRITICAL |
| 091193 |
001 |
ANDA |
BACLOFEN |
BACLOFEN |
INJECTABLE;INTRATHECAL |
0.05MG/ML |
Prescription |
No |
No |
AP |
2016/05/03
|
AMNEAL |
| 210777 |
001 |
ANDA |
BACLOFEN |
BACLOFEN |
INJECTABLE;INTRATHECAL |
0.05MG/ML |
Prescription |
No |
No |
AP |
2021/01/15
|
MAIA PHARMS INC |
