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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) 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 |
(ANDA) 062341 | 001 | 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 | SANDOZ | 1984-05-22 | No | No | RX | AT |
(ANDA) 062488 | 001 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | 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 | SANDOZ | 1985-11-06 | No | No | RX | AT |
(ANDA) 062938 | 001 | NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE | 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 | PADAGIS US | 1989-07-31 | No | No | RX | AT |
(ANDA) 064047 | 001 | NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN | GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 短杆菌肽;硫酸新霉素;硫酸多粘菌素B | SOLUTION/DROPS;OPHTHALMIC | 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML | BAUSCH AND LOMB | 1996-01-31 | No | Yes | RX | AT |
(ANDA) 060582 | 001 | NEOSPORIN | GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 短杆菌肽;硫酸新霉素;硫酸多粘菌素B | SOLUTION/DROPS;OPHTHALMIC | 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML | MONARCH PHARMS | 1982-01-01 | No | Yes | RX | AT |
(ANDA) 064053 | 001 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | 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 | BAUSCH AND LOMB | 1995-12-29 | No | Yes | RX | AT |
(ANDA) 065106 | 001 | NEOMYCIN AND POLYMYXIN B SULFATE | NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 硫酸新霉素;硫酸多粘菌素B | SOLUTION;IRRIGATION | EQ 40MG BASE/ML;200,000 UNITS/ML | XGEN PHARMS | 2006-01-31 | No | No | RX | AT |
(ANDA) 065108 | 001 | NEOMYCIN AND POLYMYXIN B SULFATE | NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 硫酸新霉素;硫酸多粘菌素B | SOLUTION;IRRIGATION | EQ 40MG BASE/ML;200,000 UNITS/ML | XGEN PHARMS | 2006-01-31 | No | No | RX | AT |
(ANDA) 062664 | 001 | NEOMYCIN AND POLYMYXIN B SULFATE | NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 硫酸新霉素;硫酸多粘菌素B | SOLUTION;IRRIGATION | EQ 40MG BASE/ML;200,000 UNITS/ML | WATSON LABS | 1986-04-08 | No | No | RX | AT |
(ANDA) 064064 | 001 | NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC | 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 | BAUSCH AND LOMB | 1995-10-30 | No | Yes | RX | AT |
(ANDA) 060707 | 001 | NEOSPORIN G.U. IRRIGANT | NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 硫酸新霉素;硫酸多粘菌素B | SOLUTION;IRRIGATION | EQ 40MG BASE/ML;200,000 UNITS/ML | MONARCH PHARMS | 1982-01-01 | No | Yes | RX | AT |
(ANDA) 060764 | 002 | NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC | 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 | PADAGIS US | 1982-01-01 | No | No | RX | AT |
(ANDA) 062423 | 001 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | 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 | SANDOZ | 1983-08-25 | No | No | RX | AT |
(ANDA) 064135 | 001 | DEXASPORIN | 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 | BAUSCH AND LOMB | 1995-09-13 | No | No | RX | AT |
(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 |
(ANDA) 064063 | 001 | NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE | 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 | BAUSCH AND LOMB | 1994-07-25 | No | No | RX | AT |
(ANDA) 065187 | 001 | NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN | GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 短杆菌肽;硫酸新霉素;硫酸多粘菌素B | SOLUTION/DROPS;OPHTHALMIC | 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML | SAPTALIS PHARMS | 2005-10-28 | No | No | 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 |