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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) 019537 | 002 | CIPRO | CIPROFLOXACIN HYDROCHLORIDE | 盐酸环丙沙星 | TABLET;ORAL | EQ 250MG BASE | BAYER HLTHCARE | 1987-10-22 | Yes | No | RX | AB |
(NDA) 019537 | 004 | CIPRO | CIPROFLOXACIN HYDROCHLORIDE | 盐酸环丙沙星 | TABLET;ORAL | EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | BAYER HLTHCARE | 1987-10-22 | Yes | No | DISCN | |
(NDA) 019537 | 003 | CIPRO | CIPROFLOXACIN HYDROCHLORIDE | 盐酸环丙沙星 | TABLET;ORAL | EQ 500MG BASE | BAYER HLTHCARE | 1987-10-22 | Yes | Yes | RX | AB |
(NDA) 019992 | 001 | CILOXAN | CIPROFLOXACIN HYDROCHLORIDE | 盐酸环丙沙星 | SOLUTION/DROPS;OPHTHALMIC | EQ 0.3% BASE | SANDOZ | 1990-12-31 | Yes | Yes | RX | AT |
(NDA) 020805 | 001 | CIPRO HC | CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE | 盐酸环丙沙星;氢化可的松 | SUSPENSION/DROPS;OTIC | EQ 0.2% BASE;1% | SANDOZ | 1998-02-10 | Yes | Yes | RX | |
(NDA) 020369 | 001 | CILOXAN | CIPROFLOXACIN HYDROCHLORIDE | 盐酸环丙沙星 | OINTMENT;OPHTHALMIC | EQ 0.3% BASE | SANDOZ | 1998-03-30 | Yes | Yes | RX | |
(NDA) 021473 | 001 | CIPRO XR | CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE | 环丙沙星;盐酸环丙沙星 | TABLET, EXTENDED RELEASE;ORAL | 212.6MG;EQ 287.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | BAYER HLTHCARE | 2002-12-13 | No | No | DISCN | |
(NDA) 021473 | 002 | CIPRO XR | CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE | 环丙沙星;盐酸环丙沙星 | TABLET, EXTENDED RELEASE;ORAL | 425.2MG;EQ 574.9MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | BAYER HLTHCARE | 2003-08-28 | No | No | DISCN | |
(ANDA) 074124 | 003 | CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | 盐酸环丙沙星 | TABLET;ORAL | EQ 750MG BASE | BARR | 2004-06-09 | No | No | DISCN | |
(ANDA) 075939 | 004 | CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | 盐酸环丙沙星 | TABLET;ORAL | EQ 750MG BASE | AMNEAL | 2004-06-09 | No | No | RX | AB |
(ANDA) 075939 | 003 | CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | 盐酸环丙沙星 | TABLET;ORAL | EQ 500MG BASE | AMNEAL | 2004-06-09 | No | No | RX | AB |
(ANDA) 076126 | 002 | CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | 盐酸环丙沙星 | TABLET;ORAL | EQ 250MG BASE | CARLSBAD | 2004-06-09 | No | No | RX | AB |
(ANDA) 074124 | 001 | CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | 盐酸环丙沙星 | TABLET;ORAL | EQ 250MG BASE | BARR | 2004-06-09 | No | No | DISCN | |
(ANDA) 076593 | 003 | CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | 盐酸环丙沙星 | TABLET;ORAL | EQ 500MG BASE | AIPING PHARM INC | 2004-06-09 | No | No | RX | AB |
(ANDA) 074124 | 002 | CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | 盐酸环丙沙星 | TABLET;ORAL | EQ 500MG BASE | BARR | 2004-06-09 | No | No | DISCN | |
(ANDA) 075939 | 002 | CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | 盐酸环丙沙星 | TABLET;ORAL | EQ 250MG BASE | AMNEAL | 2004-06-09 | No | No | RX | AB |
(ANDA) 076593 | 002 | CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | 盐酸环丙沙星 | TABLET;ORAL | EQ 250MG BASE | AIPING PHARM INC | 2004-06-09 | No | No | RX | AB |
(ANDA) 076754 | 001 | CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | 盐酸环丙沙星 | SOLUTION/DROPS;OPHTHALMIC | EQ 0.3% BASE | THE J MOLNER | 2004-06-09 | No | No | DISCN | |
(ANDA) 075928 | 001 | CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | 盐酸环丙沙星 | SOLUTION/DROPS;OPHTHALMIC | EQ 0.3% BASE | RUBICON | 2004-06-09 | No | No | RX | AT |
(ANDA) 076593 | 004 | CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | 盐酸环丙沙星 | TABLET;ORAL | EQ 750MG BASE | AIPING PHARM INC | 2004-06-09 | No | No | RX | AB |