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药智数据企业版注册数据库：增设了"联合申报"、"临床试验默认许可日期"等搜索条件，让搜索页面纬度更加全面，还有热点搜索和高级条件组合检索等检索功能 等你来体验！
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1. 列表页商品名字段中有红色标记P代表该数据有专利信息；当使用各个专利到期时间检索条件时，“有无专利”默认为有。


2. 批准日期显示1982-01-01的，实际为1982-01-01之前。


3. 更多参比制剂一次性进口信息

你目前无法使用部分二次筛选功能 请联系客服开通更多权限和功能！
导出数据
申请号 产品号 商品名 活性成分 活性成分 剂型/给药途径 规格/剂量 申请机构 批准时间 参比制剂 标准制剂 市场状态 TE
(NDA) 022281 001 ZEGERID OTC OMEPRAZOLE; SODIUM BICARBONATE 奥美拉唑;碳酸氢钠 CAPSULE;ORAL 20MG;1.1GM RILEY CONSUMER 2009-12-01 Yes Yes OTC
(NDA) 022283 001 ZEGERID OTC OMEPRAZOLE; SODIUM BICARBONATE 奥美拉唑;碳酸氢钠 FOR SUSPENSION;ORAL 20MG/PACKET;1.68GM/PACKET RILEY CONSUMER 2013-06-17 Yes Yes OTC
(NDA) 021849 001 ZEGERID OMEPRAZOLE; SODIUM BICARBONATE 奥美拉唑;碳酸氢钠 CAPSULE;ORAL 20MG;1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SALIX 2006-02-27 Yes No DISCN
(NDA) 021850 002 ZEGERID MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE 氢氧化镁;奥美拉唑;碳酸氢钠 TABLET, CHEWABLE;ORAL 700MG;40MG;600MG SANTARUS 2006-03-24 No No DISCN
(NDA) 021850 001 ZEGERID MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE 氢氧化镁;奥美拉唑;碳酸氢钠 TABLET, CHEWABLE;ORAL 700MG;20MG;600MG SANTARUS 2006-03-24 No No DISCN
(NDA) 021636 002 ZEGERID OMEPRAZOLE; SODIUM BICARBONATE 奥美拉唑;碳酸氢钠 FOR SUSPENSION;ORAL 40MG/PACKET;1.68GM/PACKET SALIX 2004-12-21 Yes No DISCN
(NDA) 021849 002 ZEGERID OMEPRAZOLE; SODIUM BICARBONATE 奥美拉唑;碳酸氢钠 CAPSULE;ORAL 40MG;1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SALIX 2006-02-27 Yes No DISCN
(NDA) 021636 001 ZEGERID OMEPRAZOLE; SODIUM BICARBONATE 奥美拉唑;碳酸氢钠 FOR SUSPENSION;ORAL 20MG/PACKET;1.68GM/PACKET SALIX 2004-06-15 Yes No DISCN
(ANDA) 076491 001 TRILYTE POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE 聚乙二醇3350;氯化钾;碳酸氢钠;氯化钠 FOR SOLUTION;ORAL 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT AUROBINDO PHARMA USA 2004-02-05 No No DISCN
(NDA) 203595 001 SUCLEAR MAGNESIUM SULFATE; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; POTASSIUM SULFATE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE 聚乙二醇3350;硫酸镁;氯化钾;硫酸钾;碳酸氢钠;氯化钠;硫酸钠 SOLUTION;ORAL 1.6GM/BOT,3.13GM/BOT,17.5GM/BOT,N/A,N/A,N/A,N/A;N/A,N/A,N/A,210GM,0.74GM,2.86GM,5.6GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** BRAINTREE LABS 2013-01-18 Yes No DISCN
(NDA) 019443 001 SODIUM BICARBONATE IN PLASTIC CONTAINER SODIUM BICARBONATE 碳酸氢钠 INJECTABLE;INJECTION 0.9MEQ/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ABBOTT 1986-06-03 Yes No DISCN
(NDA) 019443 002 SODIUM BICARBONATE IN PLASTIC CONTAINER SODIUM BICARBONATE 碳酸氢钠 INJECTABLE;INJECTION 1MEQ/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ABBOTT 1986-06-03 Yes No DISCN
(ANDA) 219701 001 SODIUM BICARBONATE SODIUM BICARBONATE 碳酸氢钠 INJECTABLE;INJECTION 1MEQ/ML ANTHEA PHARMA 2025-06-26 No No RX AP
(ANDA) 211091 003 SODIUM BICARBONATE SODIUM BICARBONATE 碳酸氢钠 INJECTABLE;INJECTION 1MEQ/ML EXELA PHARMA 2019-06-20 No Yes RX AP
(ANDA) 211091 002 SODIUM BICARBONATE SODIUM BICARBONATE 碳酸氢钠 INJECTABLE;INJECTION 0.9MEQ/ML EXELA PHARMA 2019-06-20 No Yes RX AP
(ANDA) 077394 002 SODIUM BICARBONATE SODIUM BICARBONATE 碳酸氢钠 INJECTABLE;INJECTION 1MEQ/ML HOSPIRA 2005-11-09 No No DISCN
(ANDA) 202981 001 SODIUM BICARBONATE SODIUM BICARBONATE 碳酸氢钠 INJECTABLE;INJECTION 0.5MEQ/ML HOSPIRA 2016-03-04 No Yes RX AP
(ANDA) 077394 001 SODIUM BICARBONATE SODIUM BICARBONATE 碳酸氢钠 INJECTABLE;INJECTION 0.9MEQ/ML HOSPIRA 2005-11-09 No No DISCN
(ANDA) 202494 001 SODIUM BICARBONATE SODIUM BICARBONATE 碳酸氢钠 INJECTABLE;INJECTION 0.9MEQ/ML HOSPIRA 2017-03-06 No No RX AP
(ANDA) 211091 001 SODIUM BICARBONATE SODIUM BICARBONATE 碳酸氢钠 INJECTABLE;INJECTION 0.5MEQ/ML EXELA PHARMA 2019-06-20 No Yes RX AP