药品注册申请号：075757
申请类型：ANDA (仿制药申请)
申请人：SANDOZ
申请人全名：SANDOZ INC
产品信息
产品号商品名活性成分剂型/给药途径规格/剂量参比药物(RLD)生物等效参考标准(RS)治疗等效代码该申请号批准日期该产品号批准日期市场状态
001 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS;ORAL 10MG No No AB 2003/01/28 2003/01/28 Prescription
002 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS;ORAL 20MG No Yes AB 2003/01/28 Prescription
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
2023/10/11 SUPPL-56（补充） Approval Labeling STANDARD
2022/03/04 SUPPL-54（补充） Approval Labeling STANDARD
2020/11/27 SUPPL-52（补充） Approval Labeling STANDARD
2018/06/07 SUPPL-49（补充） Approval Labeling STANDARD
2017/09/28 SUPPL-46（补充） Approval Labeling STANDARD
2015/04/14 SUPPL-43（补充） Approval Labeling STANDARD
2015/04/14 SUPPL-42（补充） Approval Labeling STANDARD
2015/04/14 SUPPL-39（补充） Approval Labeling STANDARD
2015/04/14 SUPPL-38（补充） Approval Labeling STANDARD
2014/10/31 SUPPL-32（补充） Approval Manufacturing (CMC)
2013/12/31 SUPPL-36（补充） Approval Labeling STANDARD
2013/12/31 SUPPL-33（补充） Approval Labeling STANDARD
2012/09/19 SUPPL-31（补充） Approval Labeling STANDARD
2012/02/13 SUPPL-29（补充） Approval Labeling
2012/02/13 SUPPL-28（补充） Approval Labeling
2012/02/13 SUPPL-27（补充） Approval Labeling
2011/01/07 SUPPL-25（补充） Approval Labeling
2010/02/26 SUPPL-20（补充） Approval Labeling
2007/11/16 SUPPL-16（补充） Approval Labeling
2007/03/21 SUPPL-11（补充） Approval Labeling
2006/08/24 SUPPL-13（补充） Approval Labeling
2005/09/29 SUPPL-7（补充） Approval Labeling
2005/07/12 SUPPL-8（补充） Approval Labeling
2004/05/19 SUPPL-4（补充） Approval Labeling
2003/01/28 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
与本品相关的市场独占权保护信息
关联产品号独占权代码失效日期备注
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RLDRSTE 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RLDRSTE 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
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
参考引用2
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