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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) 020090 | 001 | DIFLUCAN | FLUCONAZOLE | 氟康唑 | FOR SUSPENSION;ORAL | 50MG/5ML | PFIZER | 1993-12-23 | Yes | No | RX | AB |
(NDA) 020090 | 002 | DIFLUCAN | FLUCONAZOLE | 氟康唑 | FOR SUSPENSION;ORAL | 200MG/5ML | PFIZER | 1993-12-23 | Yes | Yes | RX | AB |
(NDA) 019950 | 001 | DIFLUCAN IN SODIUM CHLORIDE 0.9% | FLUCONAZOLE | 氟康唑 | INJECTABLE;INJECTION | 200MG/100ML (2MG/ML) | PFIZER | 1990-01-29 | Yes | No | DISCN | |
(NDA) 019950 | 002 | DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | FLUCONAZOLE | 氟康唑 | INJECTABLE;INJECTION | 200MG/100ML (2MG/ML) | PFIZER | 1990-01-29 | Yes | No | DISCN | |
(NDA) 019950 | 003 | DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER | FLUCONAZOLE | 氟康唑 | INJECTABLE;INJECTION | 200MG/100ML (2MG/ML) | PFIZER | 1992-09-29 | Yes | No | DISCN | |
(NDA) 019950 | 004 | DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | FLUCONAZOLE | 氟康唑 | INJECTABLE;INJECTION | 400MG/200ML (2MG/ML) | PFIZER | 1990-01-29 | Yes | No | DISCN | |
(NDA) 019950 | 005 | DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER | FLUCONAZOLE | 氟康唑 | INJECTABLE;INJECTION | 400MG/200ML (2MG/ML) | PFIZER | 1994-07-08 | Yes | No | DISCN | |
(NDA) 019950 | 006 | DIFLUCAN IN SODIUM CHLORIDE 0.9% | FLUCONAZOLE | 氟康唑 | INJECTABLE;INJECTION | 400MG/200ML (2MG/ML) | PFIZER | 1990-01-29 | Yes | No | DISCN | |
(NDA) 019949 | 001 | DIFLUCAN | FLUCONAZOLE | 氟康唑 | TABLET;ORAL | 50MG | PFIZER | 1990-01-29 | Yes | No | RX | AB |
(NDA) 019949 | 002 | DIFLUCAN | FLUCONAZOLE | 氟康唑 | TABLET;ORAL | 100MG | PFIZER | 1990-01-29 | Yes | No | RX | AB |
(NDA) 019949 | 003 | DIFLUCAN | FLUCONAZOLE | 氟康唑 | TABLET;ORAL | 200MG | PFIZER | 1990-01-29 | Yes | Yes | RX | AB |
(NDA) 019949 | 004 | DIFLUCAN | FLUCONAZOLE | 氟康唑 | TABLET;ORAL | 150MG | PFIZER | 1994-06-30 | Yes | No | RX | AB |