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
>>>原始批准或临时批准<<<
| 审批日期 | 提交号 | 审批结论 | 提交分类 | 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 |
|---|
| 2017/07/03 |
ORIG-1（原始申请） |
Approval |
|
|
|
|
>>>补充申请<<<
| 审批日期 | 提交号 | 审批结论 | 补充类别或审批类型 | 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 |
|---|
| 2023/07/18 |
SUPPL-8（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2022/03/04 |
SUPPL-6（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2020/12/11 |
SUPPL-5（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2018/06/07 |
SUPPL-1（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
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:OMEPRAZOLE; 剂型/给药途径:CAPSULE, DELAYED REL PELLETS;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 |
|---|
| 075410 |
001 |
ANDA |
OMEPRAZOLE |
OMEPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
10MG |
Prescription |
No |
No |
AB |
2002/11/01
|
LANNETT CO INC |
| 075757 |
001 |
ANDA |
OMEPRAZOLE |
OMEPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
10MG |
Prescription |
No |
No |
AB |
2003/01/28
|
SANDOZ |
| 075785 |
001 |
ANDA |
OMEPRAZOLE |
OMEPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
10MG |
Prescription |
No |
No |
AB |
2007/10/22
|
IMPAX LABS |
| 076048 |
001 |
ANDA |
OMEPRAZOLE |
OMEPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
10MG |
Prescription |
No |
No |
AB |
2007/10/22
|
APOTEX |
| 075576 |
003 |
ANDA |
OMEPRAZOLE |
OMEPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
10MG |
Prescription |
No |
No |
AB |
2007/10/22
|
DR REDDYS LABS LTD |
| 075347 |
001 |
ANDA |
OMEPRAZOLE |
OMEPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
10MG |
Prescription |
No |
No |
AB |
2008/05/30
|
ACTAVIS LABS FL INC |
| 078490 |
002 |
ANDA |
OMEPRAZOLE |
OMEPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
10MG |
Prescription |
No |
No |
AB |
2009/03/16
|
DR REDDYS LABS LTD |
| 091352 |
001 |
ANDA |
OMEPRAZOLE |
OMEPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
10MG |
Prescription |
No |
No |
AB |
2012/11/19
|
ZYDUS PHARMS USA INC |
| 091672 |
001 |
ANDA |
OMEPRAZOLE |
OMEPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
10MG |
Prescription |
No |
No |
AB |
2014/10/31
|
GLENMARK PHARMS LTD |
| 203270 |
001 |
ANDA |
OMEPRAZOLE |
OMEPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
10MG |
Prescription |
No |
No |
AB |
2015/08/19
|
AUROBINDO PHARMA |
| 203481 |
001 |
ANDA |
OMEPRAZOLE |
OMEPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
10MG |
Prescription |
No |
No |
AB |
2017/07/03
|
BRECKENRIDGE |
| 204012 |
001 |
ANDA |
OMEPRAZOLE |
OMEPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
10MG |
Prescription |
No |
No |
AB |
2019/09/26
|
HETERO LABS LTD III |
| 212977 |
001 |
ANDA |
OMEPRAZOLE |
OMEPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
10MG |
Prescription |
No |
No |
AB |
2020/12/10
|
XIROMED |
>>>活性成分:OMEPRAZOLE; 剂型/给药途径:CAPSULE, DELAYED REL PELLETS;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 |
|---|
| 075410 |
002 |
ANDA |
OMEPRAZOLE |
OMEPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
20MG |
Prescription |
No |
No |
AB |
2002/11/01
|
LANNETT CO INC |
| 075757 |
002 |
ANDA |
OMEPRAZOLE |
OMEPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
20MG |
Prescription |
No |
Yes |
AB |
2003/01/28
|
SANDOZ |
| 075785 |
002 |
ANDA |
OMEPRAZOLE |
OMEPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
20MG |
Prescription |
No |
No |
AB |
2007/10/22
|
IMPAX LABS |
| 076048 |
002 |
ANDA |
OMEPRAZOLE |
OMEPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
20MG |
Prescription |
No |
No |
AB |
2007/10/22
|
APOTEX |
| 075576 |
002 |
ANDA |
OMEPRAZOLE |
OMEPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
20MG |
Prescription |
No |
No |
AB |
2007/10/22
|
DR REDDYS LABS LTD |
| 075347 |
002 |
ANDA |
OMEPRAZOLE |
OMEPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
20MG |
Prescription |
No |
No |
AB |
2008/05/30
|
ACTAVIS LABS FL INC |
| 078490 |
003 |
ANDA |
OMEPRAZOLE |
OMEPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
20MG |
Prescription |
No |
No |
AB |
2009/03/16
|
DR REDDYS LABS LTD |
| 091352 |
002 |
ANDA |
OMEPRAZOLE |
OMEPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
20MG |
Prescription |
No |
No |
AB |
2012/11/19
|
ZYDUS PHARMS USA INC |
| 091672 |
002 |
ANDA |
OMEPRAZOLE |
OMEPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
20MG |
Prescription |
No |
No |
AB |
2014/10/31
|
GLENMARK PHARMS LTD |
| 203270 |
002 |
ANDA |
OMEPRAZOLE |
OMEPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
20MG |
Prescription |
No |
No |
AB |
2015/08/19
|
AUROBINDO PHARMA |
| 204661 |
001 |
ANDA |
OMEPRAZOLE |
OMEPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
20MG |
Prescription |
No |
No |
AB |
2017/06/13
|
TEVA PHARMS USA |
| 203481 |
002 |
ANDA |
OMEPRAZOLE |
OMEPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
20MG |
Prescription |
No |
No |
AB |
2017/07/03
|
BRECKENRIDGE |
| 204012 |
002 |
ANDA |
OMEPRAZOLE |
OMEPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
20MG |
Prescription |
No |
No |
AB |
2019/09/26
|
HETERO LABS LTD III |
| 212977 |
002 |
ANDA |
OMEPRAZOLE |
OMEPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
20MG |
Prescription |
No |
No |
AB |
2020/12/10
|
XIROMED |
>>>活性成分:OMEPRAZOLE; 剂型/给药途径:CAPSULE, DELAYED REL PELLETS;ORAL; 规格:40MG; 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 |
|---|
| 075347 |
003 |
ANDA |
OMEPRAZOLE |
OMEPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
40MG |
Prescription |
No |
No |
AB |
2008/05/30
|
ACTAVIS LABS FL INC |
| 075576 |
001 |
ANDA |
OMEPRAZOLE |
OMEPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
40MG |
Prescription |
No |
No |
AB |
2009/01/21
|
DR REDDYS LABS LTD |
| 075785 |
003 |
ANDA |
OMEPRAZOLE |
OMEPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
40MG |
Prescription |
No |
No |
AB |
2009/01/21
|
IMPAX LABS |
| 076048 |
003 |
ANDA |
OMEPRAZOLE |
OMEPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
40MG |
Prescription |
No |
No |
AB |
2009/01/21
|
APOTEX |
| 076515 |
001 |
ANDA |
OMEPRAZOLE |
OMEPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
40MG |
Prescription |
No |
Yes |
AB |
2009/01/21
|
SANDOZ |
| 075410 |
003 |
ANDA |
OMEPRAZOLE |
OMEPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
40MG |
Prescription |
No |
No |
AB |
2009/01/23
|
LANNETT CO INC |
| 078490 |
001 |
ANDA |
OMEPRAZOLE |
OMEPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
40MG |
Prescription |
No |
No |
AB |
2009/04/17
|
DR REDDYS LABS LTD |
| 091352 |
003 |
ANDA |
OMEPRAZOLE |
OMEPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
40MG |
Prescription |
No |
No |
AB |
2012/11/19
|
ZYDUS PHARMS USA INC |
| 091672 |
003 |
ANDA |
OMEPRAZOLE |
OMEPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
40MG |
Prescription |
No |
No |
AB |
2014/10/31
|
GLENMARK PHARMS LTD |
| 203270 |
003 |
ANDA |
OMEPRAZOLE |
OMEPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
40MG |
Prescription |
No |
No |
AB |
2015/08/19
|
AUROBINDO PHARMA |
| 203481 |
003 |
ANDA |
OMEPRAZOLE |
OMEPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
40MG |
Prescription |
No |
No |
AB |
2017/07/03
|
BRECKENRIDGE |
| 212977 |
003 |
ANDA |
OMEPRAZOLE |
OMEPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
40MG |
Prescription |
No |
No |
AB |
2024/12/27
|
XIROMED |