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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) 018374 | 001 | BACTRIM | SULFAMETHOXAZOLE; TRIMETHOPRIM | 磺胺甲噁唑;甲氧苄啶 | INJECTABLE;INJECTION | 80MG/ML;16MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUN PHARM INDS INC | 1982-01-01 | Yes | No | DISCN | |
(NDA) 017560 | 001 | BACTRIM | SULFAMETHOXAZOLE; TRIMETHOPRIM | 磺胺甲噁唑;甲氧苄啶 | SUSPENSION;ORAL | 200MG/5ML;40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUN PHARM INDUSTRIES | 1982-01-01 | Yes | No | DISCN | |
(NDA) 017377 | 001 | BACTRIM | SULFAMETHOXAZOLE; TRIMETHOPRIM | 磺胺甲噁唑;甲氧苄啶 | TABLET;ORAL | 400MG;80MG | SUN PHARM INDUSTRIES | 1982-01-01 | Yes | No | RX | AB |
(NDA) 017377 | 002 | BACTRIM DS | SULFAMETHOXAZOLE; TRIMETHOPRIM | 磺胺甲噁唑;甲氧苄啶 | TABLET;ORAL | 800MG;160MG | SUN PHARM INDUSTRIES | 1982-01-01 | Yes | Yes | RX | AB |
(NDA) 013294 | 001 | AZO GANTANOL | PHENAZOPYRIDINE HYDROCHLORIDE; SULFAMETHOXAZOLE | 盐酸非那吡啶;磺胺甲噁唑 | TABLET;ORAL | 100MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ROCHE | 1987-09-10 | Yes | No | DISCN |