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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) 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| 盐酸雷尼替丁 | TABLET;ORAL | EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GLAXO GRP LTD | 1983-06-09 | Yes | No | DISCN | |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) 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 | 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| 盐酸雷尼替丁 | TABLET;ORAL | EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GLAXO GRP LTD | 1985-12-09 | Yes | No | DISCN | |
(NDA) 019593 | 001 | ZANTAC IN PLASTIC CONTAINER | RANITIDINE HYDROCHLORIDE | 盐酸雷尼替丁 | INJECTABLE;INJECTION | EQ 50MG BASE/100ML | PAI HOLDINGS PHARM | 1986-12-17 | No | 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) 019593 | 002 | ZANTAC IN PLASTIC CONTAINER | RANITIDINE HYDROCHLORIDE | 盐酸雷尼替丁 | INJECTABLE;INJECTION | EQ 1MG BASE/ML | PAI HOLDINGS PHARM | 1991-09-27 | No | 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| 盐酸雷尼替丁 | CAPSULE;ORAL | EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GLAXOSMITHKLINE | 1994-03-08 | Yes | No | DISCN | |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| 盐酸雷尼替丁 | CAPSULE;ORAL | EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GLAXOSMITHKLINE | 1994-03-08 | Yes | No | DISCN | |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) 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 | |
(NDA) 020251 | 001 | ZANTAC 150 | RANITIDINE HYDROCHLORIDE | 盐酸雷尼替丁 | TABLET, EFFERVESCENT;ORAL | EQ 150MG BASE | GLAXO GRP LTD | 1994-03-31 | No | 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 | |
(ANDA) 074488 | 001 | RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | 盐酸雷尼替丁 | TABLET;ORAL | EQ 150MG BASE | ANI PHARMS | 1997-07-31 | No | No | DISCN | |
(ANDA) 074488 | 002 | RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | 盐酸雷尼替丁 | TABLET;ORAL | EQ 300MG BASE | ANI PHARMS | 1997-07-31 | No | No | DISCN | |
(ANDA) 074023 | 001 | RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | 盐酸雷尼替丁 | TABLET;ORAL | EQ 150MG BASE | MYLAN | 1997-08-22 | No | No | DISCN | |
(ANDA) 074023 | 002 | RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | 盐酸雷尼替丁 | TABLET;ORAL | EQ 300MG BASE | MYLAN | 1997-08-22 | No | No | DISCN | |
(ANDA) 074467 | 001 | RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | 盐酸雷尼替丁 | TABLET;ORAL | EQ 150MG BASE | SANDOZ | 1997-08-29 | No | No | RX | AB |
(ANDA) 074662 | 001 | RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | 盐酸雷尼替丁 | TABLET;ORAL | EQ 150MG BASE | BOEHRINGER INGELHEIM | 1997-08-29 | No | No | DISCN | |
(ANDA) 074662 | 002 | RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | 盐酸雷尼替丁 | TABLET;ORAL | EQ 300MG BASE | BOEHRINGER INGELHEIM | 1997-08-29 | No | No | DISCN | |
(ANDA) 074467 | 002 | RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | 盐酸雷尼替丁 | TABLET;ORAL | EQ 300MG BASE | SANDOZ | 1997-08-29 | No | No | RX | AB |
(ANDA) 074680 | 001 | RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | 盐酸雷尼替丁 | TABLET;ORAL | EQ 150MG BASE | APOTEX | 1997-09-12 | No | No | DISCN |