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 |
|---|
| 2024/05/02 |
SUPPL-8（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2019/06/03 |
SUPPL-6（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2017/09/26 |
SUPPL-3（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2017/09/26 |
SUPPL-2（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2015/03/16 |
SUPPL-1（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2012/12/18 |
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 |
Discontinued |
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 |
| 208671 |
001 |
ANDA |
LANSOPRAZOLE |
LANSOPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
15MG |
Prescription |
No |
No |
AB |
2024/11/04
|
MACLEODS PHARMS LTD |
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 |
Discontinued |
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 |
| 208671 |
002 |
ANDA |
LANSOPRAZOLE |
LANSOPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
30MG |
Prescription |
No |
No |
AB |
2024/11/04
|
MACLEODS PHARMS LTD |