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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) 022411 | 001 | OLEPTROP | TRAZODONE HYDROCHLORIDE | 盐酸曲唑酮 | TABLET, EXTENDED RELEASE;ORAL | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ANGELINI PHARMA | 2010-02-02 | Yes | No | DISCN | |
(NDA) 022411 | 002 | OLEPTROP | TRAZODONE HYDROCHLORIDE | 盐酸曲唑酮 | TABLET, EXTENDED RELEASE;ORAL | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ANGELINI PHARMA | 2010-02-02 | Yes | No | DISCN | |
(NDA) 018207 | 001 | DESYRELP | TRAZODONE HYDROCHLORIDE | 盐酸曲唑酮 | TABLET;ORAL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | PRAGMA | 1982-01-01 | Yes | No | DISCN | |
(NDA) 018207 | 002 | DESYRELP | TRAZODONE HYDROCHLORIDE | 盐酸曲唑酮 | TABLET;ORAL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | PRAGMA | 1982-01-01 | Yes | No | DISCN | |
(NDA) 018207 | 003 | DESYRELP | TRAZODONE HYDROCHLORIDE | 盐酸曲唑酮 | TABLET;ORAL | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | PRAGMA | 1985-03-25 | Yes | No | DISCN | |
(NDA) 018207 | 004 | DESYRELP | TRAZODONE HYDROCHLORIDE | 盐酸曲唑酮 | TABLET;ORAL | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | PRAGMA | 1988-11-07 | Yes | No | DISCN |