美国FDA药品橙皮书数据库
（U.S. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations）
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数据记录共 44820 条，共 2241 页，当前第 99 页
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商品名 申请号 产品号 申请类型 活性成分 剂型/给药途径 规格/剂量 是否参比药物 是否生物等效参考标准 治疗等效代码 产品批准日期 申请人 市场状态 专利及市场独占权
POLYETHYLENE GLYCOL 3350 077445 001 ANDA POLYETHYLENE GLYCOL 3350 FOR SOLUTION;ORAL 17GM/SCOOPFUL No No 2006/05/04 TEVA PHARMS DISCN 详细信息
POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES 090712 001 ANDA POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS FOR SOLUTION;ORAL 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT No No 2010/02/25 PADDOCK LLC DISCN 详细信息
POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES 204558 001 ANDA POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS FOR SOLUTION;ORAL 236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT No No AA 2018/12/21 STRIDES PHARMA RX 详细信息
POTASSIUM CHLORIDE 210902 001 ANDA POTASSIUM CHLORIDE FOR SOLUTION;ORAL 20MEQ No No AA 2019/05/23 AMNEAL RX 详细信息
POTASSIUM CHLORIDE 212183 001 ANDA POTASSIUM CHLORIDE FOR SOLUTION;ORAL 20MEQ No No AA 2019/05/06 BELCHER RX 详细信息
POTASSIUM CHLORIDE 210200 001 ANDA POTASSIUM CHLORIDE FOR SOLUTION;ORAL 20MEQ No No AA 2018/11/23 EPIC PHARMA LLC RX 详细信息
POTASSIUM CHLORIDE 213467 001 ANDA POTASSIUM CHLORIDE FOR SOLUTION;ORAL 20MEQ No No AA 2022/01/27 GRANULES RX 详细信息
POTASSIUM CHLORIDE 210241 001 ANDA POTASSIUM CHLORIDE FOR SOLUTION;ORAL 20MEQ No No AA 2018/11/21 NOVEL LABS INC RX 详细信息
POTASSIUM CHLORIDE 212816 001 ANDA POTASSIUM CHLORIDE FOR SOLUTION;ORAL 20MEQ No No AA 2023/07/12 NOVITIUM PHARMA RX 详细信息
POTASSIUM CHLORIDE 208019 001 NDA POTASSIUM CHLORIDE FOR SOLUTION;ORAL 20MEQ Yes No AA 2015/08/19 PHARMA RES SOFTWARE RX 详细信息
POTASSIUM CHLORIDE 208019 003 NDA POTASSIUM CHLORIDE FOR SOLUTION;ORAL 40MEQ Yes Yes 2023/08/25 PHARMA RES SOFTWARE RX 详细信息
POTASSIUM CHLORIDE 214108 001 ANDA POTASSIUM CHLORIDE FOR SOLUTION;ORAL 20MEQ No No AA 2022/03/24 RUBICON RX 详细信息
POTASSIUM CHLORIDE 211667 001 ANDA POTASSIUM CHLORIDE FOR SOLUTION;ORAL 20MEQ No No AA 2021/03/11 STRIDES PHARMA RX 详细信息
POTASSIUM CITRATE 019647 002 NDA POTASSIUM CITRATE FOR SOLUTION;ORAL 10MEQ/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1988/10/13 UT SW MEDCTR DISCN 详细信息
POTASSIUM CITRATE 019647 001 NDA POTASSIUM CITRATE FOR SOLUTION;ORAL 20MEQ/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1988/10/13 UT SW MEDCTR DISCN 详细信息
PREPOPIK 202535 001 NDA CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE FOR SOLUTION;ORAL 12GM/PACKET;3.5GM/PACKET;10MG/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2012/07/16 FERRING PHARMS INC DISCN 详细信息
PROSTAPHLIN 050194 001 NDA OXACILLIN SODIUM FOR SOLUTION;ORAL EQ 250MG BASE/5ML No No Approved Prior to Jan 1, 1982 APOTHECON DISCN 详细信息
PYLORI-CHEK BREATH TEST 020900 001 NDA UREA C-13 FOR SOLUTION;ORAL 100MG/VIAL No No 1999/02/04 DXS DEVICES DISCN 详细信息
SABRIL 022006 001 NDA VIGABATRIN FOR SOLUTION;ORAL 500MG/PACKET Yes Yes AA 2009/08/21 LUNDBECK PHARMS LLC RX 详细信息
SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID 212789 001 ANDA CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE FOR SOLUTION;ORAL 12GM/PACKET;3.5GM/PACKET;10MG/PACKET No Yes 2022/07/18 HETERO LABS LTD V RX 详细信息
当前数据更新日期：2024年04月25日，更多信息请点击此处查询美国FDA药品数据库
数据库说明：本数据与美国FDA官方药品橙皮书数据库同步，在官方数据基础上，提供更全面的检索方式和更简洁高效、完整的数据展现，并且可以回溯专利及市场独占权（市场排他数据）历史信息。
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