药品注册申请号：212587
申请类型：ANDA (仿制药申请)
申请人：ANDA REPOSITORY
申请人全名：ANDA REPOSITORY LLC
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 AND SODIUM BICARBONATE OMEPRAZOLE; SODIUM BICARBONATE CAPSULE;ORAL 20MG;1.1GM No No AB 2020/04/30 2020/04/30 Prescription
002 OMEPRAZOLE AND SODIUM BICARBONATE OMEPRAZOLE; SODIUM BICARBONATE CAPSULE;ORAL 40MG;1.1GM No No AB 2020/04/30 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
2020/04/30 ORIG-1（原始申请） Approval 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; SODIUM BICARBONATE 剂型/给药途径:CAPSULE;ORAL 规格:20MG;1.1GM 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
021849 001 NDA ZEGERID OMEPRAZOLE; SODIUM BICARBONATE CAPSULE;ORAL 20MG;1.1GM Discontinued Yes No AB 2006/02/27 SALIX
204068 001 ANDA OMEPRAZOLE AND SODIUM BICARBONATE OMEPRAZOLE; SODIUM BICARBONATE CAPSULE;ORAL 20MG;1.1GM Prescription No No AB 2016/07/15 DR REDDYS
204228 001 ANDA OMEPRAZOLE AND SODIUM BICARBONATE OMEPRAZOLE; SODIUM BICARBONATE CAPSULE;ORAL 20MG;1.1GM Prescription No No AB 2016/07/15 AJANTA PHARMA LTD
204922 001 ANDA OMEPRAZOLE AND SODIUM BICARBONATE OMEPRAZOLE; SODIUM BICARBONATE CAPSULE;ORAL 20MG;1.1GM Prescription No No AB 2016/08/19 AUROLIFE PHARMA LLC
207476 001 ANDA OMEPRAZOLE AND SODIUM BICARBONATE OMEPRAZOLE; SODIUM BICARBONATE CAPSULE;ORAL 20MG;1.1GM Prescription No No AB 2016/12/06 SCIEGEN PHARMS INC
203290 001 ANDA OMEPRAZOLE AND SODIUM BICARBONATE OMEPRAZOLE; SODIUM BICARBONATE CAPSULE;ORAL 20MG;1.1GM Prescription No No AB 2018/05/25 ZYDUS PHARMS
212587 001 ANDA OMEPRAZOLE AND SODIUM BICARBONATE OMEPRAZOLE; SODIUM BICARBONATE CAPSULE;ORAL 20MG;1.1GM Prescription No No AB 2020/04/30 ANDA REPOSITORY
活性成分:OMEPRAZOLE; SODIUM BICARBONATE 剂型/给药途径:CAPSULE;ORAL 规格:40MG;1.1GM 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
021849 002 NDA ZEGERID OMEPRAZOLE; SODIUM BICARBONATE CAPSULE;ORAL 40MG;1.1GM Discontinued Yes No AB 2006/02/27 SALIX
204068 002 ANDA OMEPRAZOLE AND SODIUM BICARBONATE OMEPRAZOLE; SODIUM BICARBONATE CAPSULE;ORAL 40MG;1.1GM Prescription No No AB 2016/07/15 DR REDDYS
204228 002 ANDA OMEPRAZOLE AND SODIUM BICARBONATE OMEPRAZOLE; SODIUM BICARBONATE CAPSULE;ORAL 40MG;1.1GM Prescription No Yes AB 2016/07/15 AJANTA PHARMA LTD
204922 002 ANDA OMEPRAZOLE AND SODIUM BICARBONATE OMEPRAZOLE; SODIUM BICARBONATE CAPSULE;ORAL 40MG;1.1GM Prescription No No AB 2016/08/19 AUROLIFE PHARMA LLC
207476 002 ANDA OMEPRAZOLE AND SODIUM BICARBONATE OMEPRAZOLE; SODIUM BICARBONATE CAPSULE;ORAL 40MG;1.1GM Prescription No No AB 2016/12/06 SCIEGEN PHARMS INC
203290 002 ANDA OMEPRAZOLE AND SODIUM BICARBONATE OMEPRAZOLE; SODIUM BICARBONATE CAPSULE;ORAL 40MG;1.1GM Prescription No No AB 2018/05/25 ZYDUS PHARMS
212587 002 ANDA OMEPRAZOLE AND SODIUM BICARBONATE OMEPRAZOLE; SODIUM BICARBONATE CAPSULE;ORAL 40MG;1.1GM Prescription No No AB 2020/04/30 ANDA REPOSITORY
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
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