美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=OMEPRAZOLE MAGNESIUM"
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 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
OMEPRAZOLE MAGNESIUM 206877 001 ANDA OMEPRAZOLE MAGNESIUM TABLET, DELAYED RELEASE;ORAL EQ 20MG BASE No No 2018/06/06 2018/06/06 AUROBINDO PHARMA Over-the-counter
OMEPRAZOLE MAGNESIUM 210593 001 ANDA OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE;ORAL EQ 20MG BASE No No 2018/07/20 2018/07/20 SPIL Over-the-counter
NAPROXEN AND ESOMEPRAZOLE MAGNESIUM 202461 001 ANDA ESOMEPRAZOLE MAGNESIUM; NAPROXEN TABLET, DELAYED RELEASE;ORAL EQ 20MG BASE;375MG No No 2018/09/04 (TA) -- DR REDDYS LABS LTD None (Tentative Approval)
NAPROXEN AND ESOMEPRAZOLE MAGNESIUM 202461 002 ANDA ESOMEPRAZOLE MAGNESIUM; NAPROXEN TABLET, DELAYED RELEASE;ORAL EQ 20MG BASE;500MG No No 2018/09/04 (TA) -- DR REDDYS LABS LTD None (Tentative Approval)
ESOMEPRAZOLE MAGNESIUM 209202 001 ANDA ESOMEPRAZOLE MAGNESIUM TABLET, DELAYED RELEASE;ORAL EQ 20MG BASE No No 2019/03/05 2019/03/05 P AND L Discontinued
ESOMEPRAZOLE MAGNESIUM 209647 001 ANDA ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED REL PELLETS;ORAL EQ 20MG BASE No No 2019/04/10 2019/04/10 AMNEAL PHARMS NY Discontinued
ESOMEPRAZOLE MAGNESIUM 209647 002 ANDA ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED REL PELLETS;ORAL EQ 40MG BASE No No 2019/04/10 2019/04/10 AMNEAL PHARMS NY Discontinued
ESOMEPRAZOLE MAGNESIUM 209495 001 ANDA ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED REL PELLETS;ORAL EQ 20MG BASE No No 2019/05/10 2019/05/10 GLENMARK PHARMS Prescription
ESOMEPRAZOLE MAGNESIUM 209495 002 ANDA ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED REL PELLETS;ORAL EQ 40MG BASE No No 2019/05/10 2019/05/10 GLENMARK PHARMS Prescription
ESOMEPRAZOLE MAGNESIUM 206296 001 ANDA ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED REL PELLETS;ORAL EQ 20MG BASE No No 2019/05/22 2019/05/22 ZYDUS PHARMS Prescription
ESOMEPRAZOLE MAGNESIUM 206296 002 ANDA ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED REL PELLETS;ORAL EQ 40MG BASE No No 2019/05/22 2019/05/22 ZYDUS PHARMS Prescription
ESOMEPRAZOLE MAGNESIUM 209716 001 ANDA ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE;ORAL EQ 20MG BASE No No 2019/06/05 2019/06/05 AMNEAL PHARMS NY Over-the-counter
ESOMEPRAZOLE MAGNESIUM 212376 001 ANDA ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE;ORAL EQ 20MG BASE No No 2019/10/16 2019/10/16 MYLAN Discontinued
NAPROXEN AND ESOMEPRAZOLE MAGNESIUM 204206 001 ANDA ESOMEPRAZOLE MAGNESIUM; NAPROXEN TABLET, DELAYED RELEASE;ORAL EQ 20MG BASE;375MG No No 2020/02/18 2020/02/18 DR REDDYS Prescription
NAPROXEN AND ESOMEPRAZOLE MAGNESIUM 204206 002 ANDA ESOMEPRAZOLE MAGNESIUM; NAPROXEN TABLET, DELAYED RELEASE;ORAL EQ 20MG BASE;500MG No Yes 2020/02/18 2020/02/18 DR REDDYS Prescription
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