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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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
(ANDA) 209859 | 001 | RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | 盐酸雷尼替丁 | CAPSULE;ORAL | EQ 150MG BASE | AJANTA PHARMA LTD | 2018-09-27 | No | No | DISCN | |
(NDA) 020095 | 002 | ZANTAC 300 | RANITIDINE HYDROCHLORIDE | 盐酸雷尼替丁 | CAPSULE;ORAL | EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GLAXOSMITHKLINE | 1994-03-08 | Yes | No | DISCN | |
(NDA) 020095 | 001 | ZANTAC 150 | RANITIDINE HYDROCHLORIDE | 盐酸雷尼替丁 | CAPSULE;ORAL | EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GLAXOSMITHKLINE | 1994-03-08 | Yes | No | DISCN | |
(ANDA) 075557 | 002 | RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | 盐酸雷尼替丁 | CAPSULE;ORAL | EQ 300MG BASE | TEVA | 2003-10-31 | No | No | DISCN | |
(ANDA) 075557 | 001 | RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | 盐酸雷尼替丁 | CAPSULE;ORAL | EQ 150MG BASE | TEVA | 2003-10-31 | No | No | DISCN | |
(ANDA) 074655 | 002 | RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | 盐酸雷尼替丁 | CAPSULE;ORAL | EQ 300MG BASE | SANDOZ | 1997-10-22 | No | Yes | RX | AB |
(ANDA) 074655 | 001 | RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | 盐酸雷尼替丁 | CAPSULE;ORAL | EQ 150MG BASE | SANDOZ | 1997-10-22 | No | No | RX | AB |
(ANDA) 210681 | 002 | RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | 盐酸雷尼替丁 | CAPSULE;ORAL | EQ 300MG BASE | NOVITIUM PHARMA | 2018-11-23 | No | No | DISCN | |
(ANDA) 210681 | 001 | RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | 盐酸雷尼替丁 | CAPSULE;ORAL | EQ 150MG BASE | NOVITIUM PHARMA | 2018-11-23 | No | No | DISCN | |
(ANDA) 075564 | 002 | RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | 盐酸雷尼替丁 | CAPSULE;ORAL | EQ 300MG BASE | NORVIUM BIOSCIENCE | 2000-10-27 | No | No | DISCN | |
(ANDA) 075564 | 001 | RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | 盐酸雷尼替丁 | CAPSULE;ORAL | EQ 150MG BASE | NORVIUM BIOSCIENCE | 2000-10-27 | No | No | DISCN | |
(ANDA) 209859 | 002 | RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | 盐酸雷尼替丁 | CAPSULE;ORAL | EQ 300MG BASE | AJANTA PHARMA LTD | 2018-09-27 | No | No | DISCN | |
(ANDA) 211893 | 001 | RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | 盐酸雷尼替丁 | CAPSULE;ORAL | EQ 150MG BASE | APPCO | 2019-04-05 | No | No | DISCN | |
(ANDA) 211893 | 002 | RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | 盐酸雷尼替丁 | CAPSULE;ORAL | EQ 300MG BASE | APPCO | 2019-04-05 | No | No | DISCN | |
(ANDA) 211058 | 001 | RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | 盐酸雷尼替丁 | CAPSULE;ORAL | EQ 150MG BASE | AUROBINDO PHARMA | 2018-07-16 | No | No | DISCN | |
(ANDA) 211058 | 002 | RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | 盐酸雷尼替丁 | CAPSULE;ORAL | EQ 300MG BASE | AUROBINDO PHARMA | 2018-07-16 | No | No | DISCN | |
(ANDA) 075742 | 001 | RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | 盐酸雷尼替丁 | CAPSULE;ORAL | EQ 150MG BASE | DR REDDYS LABS LTD | 2000-11-29 | No | No | RX | AB |
(ANDA) 075742 | 002 | RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | 盐酸雷尼替丁 | CAPSULE;ORAL | EQ 300MG BASE | DR REDDYS LABS LTD | 2000-11-29 | No | No | RX | AB |
(NDA) 020251 | 002 | ZANTAC 150 | RANITIDINE HYDROCHLORIDE | 盐酸雷尼替丁 | GRANULE, EFFERVESCENT;ORAL | EQ 150MG BASE/PACKET | GLAXO GRP LTD | 1994-03-31 | No | No | DISCN | |
(ANDA) 074777 | 001 | RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | 盐酸雷尼替丁 | INJECTABLE;INJECTION | EQ 25MG BASE/ML | HIKMA | 2005-03-02 | No | No | DISCN |