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 |
2023/04/06 |
SUPPL-14(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2023/04/06 |
SUPPL-11(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2023/04/06 |
SUPPL-10(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2020/08/20 |
SUPPL-6(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2020/08/20 |
SUPPL-5(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2020/08/20 |
SUPPL-4(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2020/08/20 |
SUPPL-2(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2016/07/25 |
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:LANSOPRAZOLE 剂型/给药途径:CAPSULE, DELAYED REL PELLETS;ORAL 规格:15MG 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 |
077255 |
001 |
ANDA |
LANSOPRAZOLE |
LANSOPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
15MG |
Prescription |
No |
No |
AB |
2009/11/10
|
TEVA PHARMS |
090763 |
001 |
ANDA |
LANSOPRAZOLE |
LANSOPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
15MG |
Prescription |
No |
No |
AB |
2009/11/10
|
MYLAN PHARMS INC |
090331 |
001 |
ANDA |
LANSOPRAZOLE |
LANSOPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
15MG |
Prescription |
No |
No |
AB |
2010/04/23
|
SANDOZ |
091269 |
001 |
ANDA |
LANSOPRAZOLE |
LANSOPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
15MG |
Prescription |
No |
No |
AB |
2010/10/15
|
DR REDDYS LABS LTD |
202176 |
001 |
ANDA |
LANSOPRAZOLE |
LANSOPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
15MG |
Prescription |
No |
No |
AB |
2012/09/14
|
WOCKHARDT |
201921 |
001 |
ANDA |
LANSOPRAZOLE |
LANSOPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
15MG |
Prescription |
No |
No |
AB |
2012/12/18
|
NATCO PHARMA LTD |
202366 |
001 |
ANDA |
LANSOPRAZOLE |
LANSOPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
15MG |
Prescription |
No |
No |
AB |
2013/08/19
|
ZYDUS HLTHCARE |
202637 |
001 |
ANDA |
LANSOPRAZOLE |
LANSOPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
15MG |
Discontinued |
No |
No |
AB |
2013/09/13
|
SUN PHARM |
203203 |
001 |
ANDA |
LANSOPRAZOLE |
LANSOPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
15MG |
Prescription |
No |
No |
AB |
2016/07/25
|
XIROMED |
205868 |
001 |
ANDA |
LANSOPRAZOLE |
LANSOPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
15MG |
Prescription |
No |
No |
AB |
2017/08/30
|
INVENTIA |
207156 |
001 |
ANDA |
LANSOPRAZOLE |
LANSOPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
15MG |
Prescription |
No |
No |
AB |
2017/09/28
|
CHARTWELL MOLECULAR |
207394 |
001 |
ANDA |
LANSOPRAZOLE |
LANSOPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
15MG |
Prescription |
No |
No |
AB |
2019/01/18
|
ALKEM LABS LTD |
203083 |
001 |
ANDA |
LANSOPRAZOLE |
LANSOPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
15MG |
Prescription |
No |
No |
AB |
2020/05/18
|
HETERO LABS LTD III |
活性成分:LANSOPRAZOLE 剂型/给药途径:CAPSULE, DELAYED REL PELLETS;ORAL 规格:30MG 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 |
020406 |
002 |
NDA |
PREVACID |
LANSOPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
30MG |
Prescription |
Yes |
Yes |
AB |
1995/05/10
|
TAKEDA PHARMS USA |
077255 |
002 |
ANDA |
LANSOPRAZOLE |
LANSOPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
30MG |
Prescription |
No |
No |
AB |
2009/11/10
|
TEVA PHARMS |
090763 |
002 |
ANDA |
LANSOPRAZOLE |
LANSOPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
30MG |
Prescription |
No |
No |
AB |
2009/11/10
|
MYLAN PHARMS INC |
090331 |
002 |
ANDA |
LANSOPRAZOLE |
LANSOPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
30MG |
Prescription |
No |
No |
AB |
2010/04/23
|
SANDOZ |
091269 |
002 |
ANDA |
LANSOPRAZOLE |
LANSOPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
30MG |
Prescription |
No |
No |
AB |
2010/10/15
|
DR REDDYS LABS LTD |
202176 |
002 |
ANDA |
LANSOPRAZOLE |
LANSOPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
30MG |
Prescription |
No |
No |
AB |
2012/09/14
|
WOCKHARDT |
201921 |
002 |
ANDA |
LANSOPRAZOLE |
LANSOPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
30MG |
Prescription |
No |
No |
AB |
2012/12/18
|
NATCO PHARMA LTD |
202366 |
002 |
ANDA |
LANSOPRAZOLE |
LANSOPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
30MG |
Prescription |
No |
No |
AB |
2013/08/19
|
ZYDUS HLTHCARE |
091509 |
001 |
ANDA |
LANSOPRAZOLE |
LANSOPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
30MG |
Discontinued |
No |
No |
AB |
2013/09/13
|
SUN PHARM |
203203 |
002 |
ANDA |
LANSOPRAZOLE |
LANSOPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
30MG |
Prescription |
No |
No |
AB |
2016/07/25
|
XIROMED |
205868 |
002 |
ANDA |
LANSOPRAZOLE |
LANSOPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
30MG |
Prescription |
No |
No |
AB |
2017/08/30
|
INVENTIA |
207156 |
002 |
ANDA |
LANSOPRAZOLE |
LANSOPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
30MG |
Prescription |
No |
No |
AB |
2017/09/28
|
CHARTWELL MOLECULAR |
207394 |
002 |
ANDA |
LANSOPRAZOLE |
LANSOPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
30MG |
Prescription |
No |
No |
AB |
2019/01/18
|
ALKEM LABS LTD |
203083 |
002 |
ANDA |
LANSOPRAZOLE |
LANSOPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
30MG |
Prescription |
No |
No |
AB |
2020/05/18
|
HETERO LABS LTD III |