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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 | 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| CAPOTEN | CAPTOPRIL | 卡托普利 | TABLET;ORAL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | STRIDES PHARMA | 1982-01-01 | Yes | No | DISCN | |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 | 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| CAPOTEN | CAPTOPRIL | 卡托普利 | TABLET;ORAL | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | STRIDES PHARMA | 1982-01-01 | Yes | No | DISCN | |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) 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CAPOTEN | CAPTOPRIL | 卡托普利 | TABLET;ORAL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | STRIDES PHARMA | 1982-01-01 | Yes | No | DISCN | |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 | 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CAPOTEN | CAPTOPRIL | 卡托普利 | TABLET;ORAL | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | STRIDES PHARMA | 1995-06-13 | Yes | No | DISCN | |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 | 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CAPOTEN | CAPTOPRIL | 卡托普利 | TABLET;ORAL | 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | STRIDES PHARMA | 1985-01-17 | Yes | No | DISCN | |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 | 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CAPOTEN | CAPTOPRIL | 卡托普利 | TABLET;ORAL | 37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | STRIDES PHARMA | 1986-09-17 | Yes | No | DISCN | |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 | 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| CAPOTEN | CAPTOPRIL | 卡托普利 | TABLET;ORAL | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | STRIDES PHARMA | 1995-06-13 | Yes | No | DISCN |