美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=OMEPRAZOLE"
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 RLD RS 申请号原始批准/暂定批准日期 产品号批准日期 申请人 市场状态
ESOMEPRAZOLE SODIUM 202686 001 ANDA ESOMEPRAZOLE SODIUM INJECTABLE;INTRAVENOUS EQ 20MG BASE/VIAL No No 2017/05/17 2017/05/17 MYLAN Discontinued
ESOMEPRAZOLE SODIUM 202686 002 ANDA ESOMEPRAZOLE SODIUM INJECTABLE;INTRAVENOUS EQ 40MG BASE/VIAL No No 2017/05/17 2017/05/17 MYLAN Discontinued
OMEPRAZOLE 204661 001 ANDA OMEPRAZOLE CAPSULE, DELAYED REL PELLETS;ORAL 20MG No No 2017/06/13 2017/06/13 TEVA PHARMS USA Prescription
OMEPRAZOLE 204661 002 ANDA OMEPRAZOLE CAPSULE, DELAYED REL PELLETS;ORAL 40MG No No 2017/06/13 2017/06/13 TEVA PHARMS USA Discontinued
OMEPRAZOLE 203481 001 ANDA OMEPRAZOLE CAPSULE, DELAYED REL PELLETS;ORAL 10MG No No 2017/07/03 2017/07/03 BRECKENRIDGE Prescription
OMEPRAZOLE 203481 002 ANDA OMEPRAZOLE CAPSULE, DELAYED REL PELLETS;ORAL 20MG No No 2017/07/03 2017/07/03 BRECKENRIDGE Prescription
OMEPRAZOLE 203481 003 ANDA OMEPRAZOLE CAPSULE, DELAYED REL PELLETS;ORAL 40MG No No 2017/07/03 2017/07/03 BRECKENRIDGE Prescription
OMEPRAZOLE 209400 001 NDA OMEPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 20MG Yes Yes 2017/07/05 2017/07/05 DEXCEL Over-the-counter
ESOMEPRAZOLE MAGNESIUM 207193 001 ANDA ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE;ORAL EQ 20MG BASE No No 2017/08/18 2017/08/18 PERRIGO R AND D Over-the-counter
ESOMEPRAZOLE MAGNESIUM 205563 001 ANDA ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED REL PELLETS;ORAL EQ 20MG BASE No No 2017/09/01 2017/09/01 LANNETT CO INC Prescription
ESOMEPRAZOLE MAGNESIUM 205563 002 ANDA ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED REL PELLETS;ORAL EQ 40MG BASE No No 2017/09/01 2017/09/01 LANNETT CO INC Prescription
ESOMEPRAZOLE MAGNESIUM 209339 001 ANDA ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE;ORAL EQ 20MG BASE No No 2017/10/16 2017/10/16 AUROBINDO PHARMA Over-the-counter
ESOMEPRAZOLE MAGNESIUM 208333 001 ANDA ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED REL PELLETS;ORAL EQ 20MG BASE No No 2017/10/20 2017/10/20 ALKEM LABS LTD Prescription
ESOMEPRAZOLE MAGNESIUM 208333 002 ANDA ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED REL PELLETS;ORAL EQ 40MG BASE No No 2017/10/20 2017/10/20 ALKEM LABS LTD Prescription
OMEPRAZOLE AND SODIUM BICARBONATE 203345 001 ANDA OMEPRAZOLE; SODIUM BICARBONATE CAPSULE;ORAL 20MG;1.1GM No No 2018/03/16 2018/03/16 ZYDUS Over-the-counter
ESOMEPRAZOLE MAGNESIUM 209735 001 ANDA ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED REL PELLETS;ORAL EQ 20MG BASE No No 2018/04/30 2018/04/30 SUN PHARM Prescription
ESOMEPRAZOLE MAGNESIUM 209735 002 ANDA ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED REL PELLETS;ORAL EQ 40MG BASE No No 2018/04/30 2018/04/30 SUN PHARM Prescription
ESOMEPRAZOLE MAGNESIUM 207673 001 ANDA ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE;ORAL EQ 20MG BASE No No 2018/05/15 2018/05/15 DR REDDYS Over-the-counter
ESOMEPRAZOLE MAGNESIUM 207265 001 ANDA ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED REL PELLETS;ORAL EQ 40MG BASE No No 2018/05/18 2018/05/18 HEC PHARM Discontinued
ESOMEPRAZOLE MAGNESIUM 207265 002 ANDA ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED REL PELLETS;ORAL EQ 20MG BASE No No 2018/05/18 2018/05/18 HEC PHARM Discontinued
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