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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 |
(ANDA) 215738 | 001 | FLUCONAZOLE | FLUCONAZOLE | 氟康唑 | FOR SUSPENSION;ORAL | 200MG/5ML | ZHEJIANG POLY PHARM | 2023-09-21 | No | No | RX | AB |
(ANDA) 076918 | 002 | FLUCONAZOLE | FLUCONAZOLE | 氟康唑 | FOR SUSPENSION;ORAL | 200MG/5ML | TARO PHARM INDS | 2006-12-18 | No | No | DISCN | |
(ANDA) 076918 | 001 | FLUCONAZOLE | FLUCONAZOLE | 氟康唑 | FOR SUSPENSION;ORAL | 50MG/5ML | TARO PHARM INDS | 2006-12-18 | No | No | DISCN | |
(ANDA) 076332 | 002 | FLUCONAZOLE | FLUCONAZOLE | 氟康唑 | FOR SUSPENSION;ORAL | 200MG/5ML | SUN PHARM INDS LTD | 2004-07-29 | No | No | DISCN | |
(ANDA) 076332 | 001 | FLUCONAZOLE | FLUCONAZOLE | 氟康唑 | FOR SUSPENSION;ORAL | 50MG/5ML | SUN PHARM INDS LTD | 2004-07-29 | No | No | DISCN | |
(ANDA) 077523 | 002 | FLUCONAZOLE | FLUCONAZOLE | 氟康唑 | FOR SUSPENSION;ORAL | 200MG/5ML | IVAX SUB TEVA PHARMS | 2007-09-12 | No | No | DISCN | |
(ANDA) 077523 | 001 | FLUCONAZOLE | FLUCONAZOLE | 氟康唑 | FOR SUSPENSION;ORAL | 50MG/5ML | IVAX SUB TEVA PHARMS | 2007-09-12 | No | No | DISCN | |
(ANDA) 076246 | 002 | FLUCONAZOLE | FLUCONAZOLE | 氟康唑 | FOR SUSPENSION;ORAL | 200MG/5ML | HIKMA | 2004-07-29 | No | No | DISCN | |
(ANDA) 076246 | 001 | FLUCONAZOLE | FLUCONAZOLE | 氟康唑 | FOR SUSPENSION;ORAL | 50MG/5ML | HIKMA | 2004-07-29 | No | No | DISCN | |
(ANDA) 079150 | 002 | FLUCONAZOLE | FLUCONAZOLE | 氟康唑 | FOR SUSPENSION;ORAL | 200MG/5ML | AUROBINDO PHARMA | 2009-09-18 | No | No | RX | AB |
(ANDA) 079150 | 001 | FLUCONAZOLE | FLUCONAZOLE | 氟康唑 | FOR SUSPENSION;ORAL | 50MG/5ML | AUROBINDO PHARMA | 2009-09-18 | No | No | RX | AB |
(NDA) 020090 | 002 | DIFLUCAN | FLUCONAZOLE | 氟康唑 | FOR SUSPENSION;ORAL | 200MG/5ML | PFIZER | 1993-12-23 | Yes | Yes | RX | AB |
(ANDA) 078764 | 001 | FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER | FLUCONAZOLE | 氟康唑 | INJECTABLE;INJECTION | 200MG/100ML (2MG/ML) | HIKMA FARMACEUTICA | 2012-01-30 | No | 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 | 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 | 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) 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 | 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 | |
(ANDA) 078764 | 002 | FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER | FLUCONAZOLE | 氟康唑 | INJECTABLE;INJECTION | 400MG/200ML (2MG/ML) | HIKMA FARMACEUTICA | 2012-01-30 | No | No | DISCN |