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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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
(ANDA) 062521 | 001 | OTOCORT | 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 | ACTAVIS LABS FL INC | 1985-07-11 | No | No | DISCN | |
(ANDA) 065220 | 001 | NEOMYCIN SULFATE | NEOMYCIN SULFATE | 硫酸新霉素 | TABLET;ORAL | 500MG | ADRASTEA PHARMA | 2006-07-28 | No | No | RX | AA |
(NDA) 050344 | 002 | STATROL | NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 硫酸新霉素;硫酸多粘菌素B | OINTMENT;OPHTHALMIC | EQ 3.5MG BASE/GM;10,000 UNITS/GM | ALCON | 1982-01-01 | No | No | DISCN | |
(NDA) 050456 | 001 | STATROL | NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 硫酸新霉素;硫酸多粘菌素B | SOLUTION/DROPS;OPHTHALMIC | EQ 3.5MG BASE/ML;16,250 UNITS/ML | ALCON | 1982-01-01 | No | No | DISCN | |
(ANDA) 062339 | 001 | STATROL | NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 硫酸新霉素;硫酸多粘菌素B | SOLUTION/DROPS;OPHTHALMIC | EQ 3.5MG BASE/ML;16,250 UNITS/ML | ALCON | 1984-11-30 | No | No | DISCN | |
(ANDA) 062721 | 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 | SUSPENSION/DROPS;OPHTHALMIC | 0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | ALCON PHARMS LTD | 1986-11-17 | No | No | DISCN | |
(ANDA) 062714 | 001 | NEOMYCIN SULFATE-DEXAMETHASONE SODIUM PHOSPHATE | DEXAMETHASONE SODIUM PHOSPHATE; NEOMYCIN SULFATE | 地塞米松磷酸钠;硫酸新霉素 | SOLUTION/DROPS;OPHTHALMIC | EQ 0.1% PHOSPHATE;EQ 3.5MG BASE/ML | ALCON PHARMS LTD | 1986-07-21 | No | No | DISCN | |
(NDA) 050081 | 002 | POLY-PRED | NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PREDNISOLONE ACETATE | 硫酸新霉素;硫酸多粘菌素B;醋酸泼尼松龙 | SUSPENSION/DROPS;OPHTHALMIC | EQ 0.35% BASE;10,000 UNITS/ML;0.5% | ALLERGAN | 1982-01-01 | No | No | DISCN | |
(ANDA) 060731 | 002 | BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE | BACITRACIN; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 杆菌肽;醋酸氢化可的松;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 | ALTANA | 1982-01-01 | No | No | DISCN | |
(ANDA) 065468 | 001 | NEOMYCIN SULFATE | NEOMYCIN SULFATE | 硫酸新霉素 | TABLET;ORAL | 500MG | AVIV PHARMA | 2010-03-29 | No | No | DISCN | |
(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) 064065 | 001 | OTICAIR | 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 | BAUSCH AND LOMB | 1996-08-28 | 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 |
(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) 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) 064055 | 001 | NEOMYCIN SULFATE AND DEXAMETHASONE SODIUM PHOSPHATE | DEXAMETHASONE SODIUM PHOSPHATE; NEOMYCIN SULFATE | 地塞米松磷酸钠;硫酸新霉素 | SOLUTION/DROPS;OPHTHALMIC | EQ 0.1% PHOSPHATE;EQ 3.5MG BASE/ML | BAUSCH AND LOMB | 1995-10-30 | No | No | DISCN | |
(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) 064068 | 001 | NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE | 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 | BAUSCH AND LOMB | 1995-10-30 | No | Yes | RX | |
(NDA) 050238 | 001 | NEO-CORT-DOME | ACETIC ACID, GLACIAL; HYDROCORTISONE; NEOMYCIN SULFATE | 冰醋酸;氢化可的松;硫酸新霉素 | SUSPENSION/DROPS;OTIC | 2%;1%;EQ 0.35% BASE | BAYER PHARMS | 1982-01-01 | 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 |