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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) 050065 | 002 | MAXITROL | DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 地塞米松;硫酸新霉素;硫酸多粘菌素B | OINTMENT;OPHTHALMIC | 0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM | SANDOZ | 1982-01-01 | Yes | Yes | RX | AT |
(NDA) 050416 | 002 | CORTISPORIN | BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 杆菌肽锌;氢化可的松;硫酸新霉素;硫酸多粘菌素B | OINTMENT;OPHTHALMIC | 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CASPER PHARMA LLC | 1982-01-01 | Yes | No | DISCN | |
(NDA) 060613 | 001 | CASPORYN HC | HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 氢化可的松;硫酸新霉素;硫酸多粘菌素B | SUSPENSION/DROPS;OTIC | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | CASPER PHARMA LLC | 1982-01-01 | Yes | Yes | RX | AT |
(NDA) 050023 | 002 | MAXITROL | DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 地塞米松;硫酸新霉素;硫酸多粘菌素B | SUSPENSION/DROPS;OPHTHALMIC | 0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | HARROW EYE | 1982-01-01 | Yes | Yes | RX | AT |
(NDA) 050417 | 001 | LUMI-SPORYN | BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 杆菌肽锌;硫酸新霉素;硫酸多粘菌素B | OINTMENT;OPHTHALMIC | 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for s or e reasons** | CASPER PHARMA LLC | 1982-01-01 | Yes | No | RX | AT |
(NDA) 050356 | 001 | COLY-MYCIN S | COLISTIN SULFATE; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; THONZONIUM BROMIDE | 硫酸粘菌素;醋酸氢化可的松;硫酸新霉素;通佐溴胺 | SUSPENSION/DROPS;OTIC | EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML | ENDO OPERATIONS | 1982-01-01 | Yes | Yes | RX | |
(NDA) 050479 | 001 | CORTISPORIN | HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 氢化可的松;硫酸新霉素;硫酸多粘菌素B | SOLUTION/DROPS;OTIC | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | MONARCH PHARMS | 1982-01-01 | Yes | No | DISCN | |
(NDA) 050218 | 001 | CORTISPORIN | HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 醋酸氢化可的松;硫酸新霉素;硫酸多粘菌素B | CREAM;TOPICAL | 0.5%;EQ 3.5MG BASE/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | MONARCH PHARMS | 1985-08-09 | Yes | No | DISCN | |
(NDA) 050168 | 002 | CORTISPORIN | BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 杆菌肽锌;氢化可的松;硫酸新霉素;硫酸多粘菌素B | OINTMENT;TOPICAL | 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | MONARCH PHARMS | 1984-05-04 | Yes | No | DISCN | |
(ANDA) 061049 | 002 | NEO-CORTEF | HYDROCORTISONE ACETATE; NEOMYCIN SULFATE | 醋酸氢化可的松;硫酸新霉素 | CREAM;TOPICAL | 2.5%;EQ 3.5MG BASE/GM | PHARMACIA AND UPJOHN | 1982-01-01 | No | No | DISCN | |
(ANDA) 062411 | 001 | DEXASPORIN | DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 地塞米松;硫酸新霉素;硫酸多粘菌素B | OINTMENT;OPHTHALMIC | 0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM | PHARMAFAIR | 1983-05-16 | No | No | DISCN | |
(ANDA) 060304 | 001 | NEOMYCIN SULFATE | NEOMYCIN SULFATE | 硫酸新霉素 | TABLET;ORAL | 500MG | TEVA | 1982-01-01 | No | Yes | RX | AA |
(ANDA) 062598 | 001 | MYTREX A | NEOMYCIN SULFATE; TRIAMCINOLONE ACETONIDE | 硫酸新霉素;曲安奈德 | CREAM;TOPICAL | EQ 3.5MG BASE/GM;0.1% | SAVAGE LABS | 1986-07-21 | No | No | DISCN | |
(ANDA) 062167 | 001 | BACITRACIN-NEOMYCIN-POLYMYXIN | BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 杆菌肽锌;硫酸新霉素;硫酸多粘菌素B | OINTMENT;OPHTHALMIC | 400 UNITS/GM;EQ 3.5MG BASE/GM;5,000 UNITS/GM | PHARMADERM | 1982-01-01 | No | No | DISCN | |
(ANDA) 062386 | 001 | BACITRACIN ZINC-NEOMYCIN SULFATE-POLYMYXIN B SULFATE | BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 杆菌肽锌;硫酸新霉素;硫酸多粘菌素B | OINTMENT;OPHTHALMIC | 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM | PHARMAFAIR | 1982-09-09 | No | No | DISCN | |
(NDA) 050176 | 002 | NEOSPORIN | NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 硫酸新霉素;硫酸多粘菌素B | CREAM;TOPICAL | EQ 3.5MG BASE/GM;10,000 UNITS/GM | GLAXOSMITHKLINE | 1985-01-14 | No | No | DISCN | |
(ANDA) 062595 | 001 | NEOMYCIN SULFATE-TRIAMCINOLONE ACETONIDE | NEOMYCIN SULFATE; TRIAMCINOLONE ACETONIDE | 硫酸新霉素;曲安奈德 | CREAM;TOPICAL | EQ 3.5MG BASE/GM;0.1% | PHARMADERM | 1986-07-21 | No | No | DISCN | |
(NDA) 050237 | 005 | NEO-CORT-DOME | HYDROCORTISONE; NEOMYCIN SULFATE | 氢化可的松;硫酸新霉素 | CREAM;TOPICAL | 1%;EQ 3.5MG BASE/GM | BAYER PHARMS | 1984-06-05 | No | No | DISCN | |
(ANDA) 060700 | 001 | NEO-SYNALAR | FLUOCINOLONE ACETONIDE; NEOMYCIN SULFATE | 醋酸氟轻松;硫酸新霉素 | CREAM;TOPICAL | 0.025%;EQ 3.5MG BASE/GM | MEDIMETRIKS PHARMS | 1982-01-01 | No | Yes | RX | |
(ANDA) 061049 | 001 | NEO-CORTEF | HYDROCORTISONE ACETATE; NEOMYCIN SULFATE | 醋酸氢化可的松;硫酸新霉素 | CREAM;TOPICAL | 1%;EQ 3.5MG BASE/GM | PHARMACIA AND UPJOHN | 1982-01-01 | No | No | DISCN |