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 |
2020/05/27 |
SUPPL-2(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2007/10/31 |
ORIG-1(原始申请) |
Approval |
|
|
|
|
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:TABLET;ORAL 规格:20MG 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 |
072235 |
001 |
ANDA |
BACLOFEN |
BACLOFEN |
TABLET;ORAL |
20MG |
Prescription |
No |
Yes |
AB |
1988/07/21
|
IVAX SUB TEVA PHARMS |
074584 |
002 |
ANDA |
BACLOFEN |
BACLOFEN |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
1996/08/19
|
UPSHER SMITH LABS |
077068 |
001 |
ANDA |
BACLOFEN |
BACLOFEN |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2005/08/30
|
ENDO OPERATIONS |
077241 |
001 |
ANDA |
BACLOFEN |
BACLOFEN |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2005/12/20
|
LANNETT CO INC |
077971 |
002 |
ANDA |
BACLOFEN |
BACLOFEN |
TABLET;ORAL |
20MG |
Discontinued |
No |
No |
AB |
2007/10/26
|
IMPAX |
077088 |
001 |
ANDA |
BACLOFEN |
BACLOFEN |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2007/10/31
|
OXFORD PHARMS |
078401 |
001 |
ANDA |
BACLOFEN |
BACLOFEN |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2009/09/18
|
NORTHSTAR HLTHCARE |
209102 |
003 |
ANDA |
BACLOFEN |
BACLOFEN |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2017/11/28
|
RUBICON |
211659 |
002 |
ANDA |
BACLOFEN |
BACLOFEN |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2018/11/23
|
ZYDUS LIFESCIENCES |
212067 |
002 |
ANDA |
BACLOFEN |
BACLOFEN |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2020/07/09
|
UNICHEM |
212378 |
002 |
ANDA |
BACLOFEN |
BACLOFEN |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2020/10/09
|
INNOGENIX |
214374 |
003 |
ANDA |
BACLOFEN |
BACLOFEN |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2021/03/05
|
RISING |
214099 |
002 |
ANDA |
BACLOFEN |
BACLOFEN |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2021/07/13
|
AUROBINDO PHARMA LTD |
214114 |
002 |
ANDA |
BACLOFEN |
BACLOFEN |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2021/07/16
|
BEXIMCO PHARMS USA |
215885 |
003 |
ANDA |
BACLOFEN |
BACLOFEN |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2022/01/25
|
MANKIND PHARMA |
217687 |
003 |
ANDA |
BACLOFEN |
BACLOFEN |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2023/11/08
|
MICRO LABS |
217788 |
002 |
ANDA |
BACLOFEN |
BACLOFEN |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2024/01/10
|
GRAVITI PHARMS |
活性成分:BACLOFEN 剂型/给药途径:TABLET;ORAL 规格:10MG 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 |
077089 |
001 |
|
BACLOFEN |
BACLOFEN |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
--
|
|
078504 |
001 |
ANDA |
BACLOFEN |
BACLOFEN |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
--
|
NORTHSTAR HLTHCARE |
072234 |
001 |
ANDA |
BACLOFEN |
BACLOFEN |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
1988/07/21
|
IVAX SUB TEVA PHARMS |
074584 |
001 |
ANDA |
BACLOFEN |
BACLOFEN |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
1996/08/19
|
UPSHER SMITH LABS |
077068 |
002 |
ANDA |
BACLOFEN |
BACLOFEN |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2005/08/30
|
ENDO OPERATIONS |
077241 |
002 |
ANDA |
BACLOFEN |
BACLOFEN |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2007/07/06
|
LANNETT CO INC |
077971 |
001 |
ANDA |
BACLOFEN |
BACLOFEN |
TABLET;ORAL |
10MG |
Discontinued |
No |
No |
AB |
2007/10/26
|
IMPAX |
077088 |
002 |
ANDA |
BACLOFEN |
BACLOFEN |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2007/10/31
|
OXFORD PHARMS |
078401 |
002 |
ANDA |
BACLOFEN |
BACLOFEN |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2009/09/18
|
NORTHSTAR HLTHCARE |
209102 |
002 |
ANDA |
BACLOFEN |
BACLOFEN |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2017/11/28
|
RUBICON |
211659 |
001 |
ANDA |
BACLOFEN |
BACLOFEN |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2018/11/23
|
ZYDUS LIFESCIENCES |
212067 |
001 |
ANDA |
BACLOFEN |
BACLOFEN |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2020/07/09
|
UNICHEM |
212378 |
001 |
ANDA |
BACLOFEN |
BACLOFEN |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2020/10/09
|
INNOGENIX |
214374 |
002 |
ANDA |
BACLOFEN |
BACLOFEN |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2021/03/05
|
RISING |
214099 |
001 |
ANDA |
BACLOFEN |
BACLOFEN |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2021/07/13
|
AUROBINDO PHARMA LTD |
214114 |
001 |
ANDA |
BACLOFEN |
BACLOFEN |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2021/07/16
|
BEXIMCO PHARMS USA |
215885 |
002 |
ANDA |
BACLOFEN |
BACLOFEN |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2022/01/25
|
MANKIND PHARMA |
217687 |
002 |
ANDA |
BACLOFEN |
BACLOFEN |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2023/11/08
|
MICRO LABS |
217788 |
001 |
ANDA |
BACLOFEN |
BACLOFEN |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2024/01/10
|
GRAVITI PHARMS |