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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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
(NDA) 021698 | 001 | ZANTAC 150 | RANITIDINE HYDROCHLORIDE | 盐酸雷尼替丁 | TABLET;ORAL | EQ 150MG BASE | CHATTEM SANOFI | 2004-08-31 | Yes | No | DISCN | |
(NDA) 021698 | 002 | ZANTAC 150 | RANITIDINE HYDROCHLORIDE | 盐酸雷尼替丁 | TABLET;ORAL | EQ 150MG BASE | CHATTEM SANOFI | 2007-03-13 | Yes | No | DISCN | |
(NDA) 020745 | 001 | ZANTAC 75 | RANITIDINE HYDROCHLORIDE | 盐酸雷尼替丁 | TABLET, EFFERVESCENT;ORAL | EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CHATTEM SANOFI | 1998-02-26 | Yes | No | DISCN | |
(NDA) 020520 | 001 | ZANTAC 75 | RANITIDINE HYDROCHLORIDE | 盐酸雷尼替丁 | TABLET;ORAL | EQ 75MG BASE | CHATTEM SANOFI | 1995-12-19 | 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| 盐酸雷尼替丁 | CAPSULE;ORAL | EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GLAXOSMITHKLINE | 1994-03-08 | Yes | No | DISCN | |
(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| 盐酸雷尼替丁 | CAPSULE;ORAL | EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GLAXOSMITHKLINE | 1994-03-08 | Yes | No | DISCN | |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) 019675 | 001 | ZANTAC | RANITIDINE HYDROCHLORIDE | 盐酸雷尼替丁 | SYRUP;ORAL | EQ 15MG BASE/ML | GLAXO GRP LTD | 1988-12-30 | Yes | No | DISCN | |
(NDA) 019090 | 001 | ZANTAC | RANITIDINE HYDROCHLORIDE | 盐酸雷尼替丁 | INJECTABLE;INJECTION | EQ 25MG BASE/ML | PAI HOLDINGS PHARM | 1984-10-19 | Yes | No | DISCN | |
(NDA) 018703 | 001 | ZANTAC 150 | RANITIDINE HYDROCHLORIDE | 盐酸雷尼替丁 | TABLET;ORAL | EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GLAXO GRP LTD | 1983-06-09 | Yes | No | DISCN | |
(NDA) 018703 | 002 | ZANTAC 300 | RANITIDINE HYDROCHLORIDE | 盐酸雷尼替丁 | TABLET;ORAL | EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GLAXO GRP LTD | 1985-12-09 | Yes | No | DISCN |