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 |
|---|
| 2020/05/06 |
SUPPL-38（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2010/12/01 |
SUPPL-30（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2009/04/03 |
SUPPL-26（补充） |
Approval |
Labeling |
|
|
|
| 2002/07/29 |
SUPPL-12（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2001/06/04 |
SUPPL-10（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2000/01/28 |
SUPPL-7（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1999/04/19 |
SUPPL-6（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1998/12/01 |
SUPPL-5（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1996/09/05 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1995/07/12 |
SUPPL-2（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1995/04/06 |
SUPPL-3（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1988/07/21 |
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: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
|
ANDAS 5 HOLDING |
| 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 |