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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) 018343 | 005 | CAPOTEN | CAPTOPRIL | 卡托普利 | TABLET;ORAL | 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | STRIDES PHARMA | 1985-01-17 | Yes | No | DISCN | |
(NDA) 018343 | 004 | CAPOTEN | CAPTOPRIL | 卡托普利 | TABLET;ORAL | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | STRIDES PHARMA | 1995-06-13 | Yes | No | DISCN | |
(NDA) 018343 | 003 | CAPOTEN | CAPTOPRIL | 卡托普利 | TABLET;ORAL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | STRIDES PHARMA | 1982-01-01 | Yes | No | DISCN | |
(NDA) 018343 | 007 | CAPOTEN | CAPTOPRIL | 卡托普利 | TABLET;ORAL | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | STRIDES PHARMA | 1995-06-13 | Yes | No | DISCN | |
(NDA) 018343 | 001 | CAPOTEN | CAPTOPRIL | 卡托普利 | TABLET;ORAL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | STRIDES PHARMA | 1982-01-01 | Yes | No | DISCN | |
(NDA) 018343 | 006 | CAPOTEN | CAPTOPRIL | 卡托普利 | TABLET;ORAL | 37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | STRIDES PHARMA | 1986-09-17 | Yes | No | DISCN | |
(NDA) 018343 | 002 | CAPOTEN | CAPTOPRIL | 卡托普利 | TABLET;ORAL | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | STRIDES PHARMA | 1982-01-01 | Yes | No | DISCN | |
(NDA) 018709 | 001 | CAPOZIDE 25/15 | CAPTOPRIL; HYDROCHLOROTHIAZIDE | 卡托普利;氢氯噻嗪 | TABLET;ORAL | 25MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | APOTHECON | 1984-10-12 | Yes | No | DISCN | |
(NDA) 018709 | 002 | CAPOZIDE 25/25 | CAPTOPRIL; HYDROCHLOROTHIAZIDE | 卡托普利;氢氯噻嗪 | TABLET;ORAL | 25MG;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | APOTHECON | 1984-10-12 | Yes | No | DISCN | |
(NDA) 018709 | 004 | CAPOZIDE 50/15 | CAPTOPRIL; HYDROCHLOROTHIAZIDE | 卡托普利;氢氯噻嗪 | TABLET;ORAL | 50MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | APOTHECON | 1984-10-12 | Yes | No | DISCN | |
(NDA) 018709 | 003 | CAPOZIDE 50/25 | CAPTOPRIL; HYDROCHLOROTHIAZIDE | 卡托普利;氢氯噻嗪 | TABLET;ORAL | 50MG;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | APOTHECON | 1984-10-12 | Yes | No | DISCN | |
(ANDA) 074677 | 002 | CAPTOPRIL | CAPTOPRIL | 卡托普利 | TABLET;ORAL | 25MG | ANDAS 5 HOLDING | 1997-05-30 | No | No | RX | AB |
(ANDA) 074677 | 004 | CAPTOPRIL | CAPTOPRIL | 卡托普利 | TABLET;ORAL | 12.5MG | ANDAS 5 HOLDING | 1997-05-30 | No | No | RX | AB |
(ANDA) 212809 | 004 | CAPTOPRIL | CAPTOPRIL | 卡托普利 | TABLET;ORAL | 100MG | AJANTA PHARMA LTD | 2019-12-13 | No | No | RX | AB |
(ANDA) 212809 | 003 | CAPTOPRIL | CAPTOPRIL | 卡托普利 | TABLET;ORAL | 50MG | AJANTA PHARMA LTD | 2019-12-13 | No | No | RX | AB |
(ANDA) 212809 | 002 | CAPTOPRIL | CAPTOPRIL | 卡托普利 | TABLET;ORAL | 25MG | AJANTA PHARMA LTD | 2019-12-13 | No | No | RX | AB |
(ANDA) 212809 | 001 | CAPTOPRIL | CAPTOPRIL | 卡托普利 | TABLET;ORAL | 12.5MG | AJANTA PHARMA LTD | 2019-12-13 | No | No | RX | AB |
(ANDA) 214442 | 004 | CAPTOPRIL | CAPTOPRIL | 卡托普利 | TABLET;ORAL | 100MG | AIPING PHARM INC | 2023-01-27 | No | No | RX | AB |
(ANDA) 214442 | 003 | CAPTOPRIL | CAPTOPRIL | 卡托普利 | TABLET;ORAL | 50MG | AIPING PHARM INC | 2023-01-27 | No | No | RX | AB |
(ANDA) 214442 | 002 | CAPTOPRIL | CAPTOPRIL | 卡托普利 | TABLET;ORAL | 25MG | AIPING PHARM INC | 2023-01-27 | No | No | RX | AB |