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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) 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 | |
(ANDA) 062166 | 002 | BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE | BACITRACIN ZINC; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 杆菌肽锌;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 | PADAGIS US | 1982-01-01 | No | Yes | RX | |
(ANDA) 062389 | 001 | ZINC BACITRACIN,NEOMYCIN SULFATE,POLYMYXIN B SULFATE & 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 | PHARMAFAIR | 1982-07-02 | No | No | DISCN | |
(ANDA) 065213 | 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 | SCIEGEN PHARMS INC | 2012-07-25 | No | No | DISCN | |
(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) 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400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CASPER PHARMA LLC | 1982-01-01 | Yes | No | DISCN | |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) 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| 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | MONARCH PHARMS | 1984-05-04 | Yes | No | DISCN | |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) 062381 | 001 | NEOMYCIN & POLYMYXIN B SULFATES & BACITRACIN ZINC & 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;TOPICAL | 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM | PHARMAFAIR | 1985-09-06 | No | No | DISCN | |
(ANDA) 062499 | 001 | LANABIOTIC | BACITRACIN ZINC; LIDOCAINE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 杆菌肽锌;利多卡因;硫酸新霉素;硫酸多粘菌素B | OINTMENT;TOPICAL | 400 UNITS/GM;40MG/GM;EQ 5MG BASE/GM;5,000 UNITS/GM | COMBE | 1985-06-03 | 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 | |
(ANDA) 060647 | 001 | NEO-POLYCIN | 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 | 500 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM | DOW PHARM | 1982-01-01 | No | No | DISCN | |
(ANDA) 065088 | 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 | SCIEGEN PHARMS INC | 2004-02-06 | No | No | DISCN | |
(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 |
(ANDA) 062833 | 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;TOPICAL | 400 UNITS/GM;EQ 3.5MG BASE/GM;5,000 UNITS/GM | NASKA | 1987-11-09 | 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) 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) 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) 061048 | 001 | MYCITRACIN | BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 杆菌肽;硫酸新霉素;硫酸多粘菌素B | OINTMENT;OPHTHALMIC | 500 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM | PHARMACIA AND UPJOHN | 1982-01-01 | No | No | DISCN | |
(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 |