美国FDA药品橙皮书数据库
(U.S. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations)
商品名 申请号 产品号 申请类型 活性成分 剂型/给药途径 规格/剂量 是否参比药物 是否生物等效参考标准 治疗等效代码 产品批准日期 申请人 市场状态 专利及市场独占权
VEXOL 020474 001 NDA RIMEXOLONE SUSPENSION/DROPS;OPHTHALMIC 1% No No 1994/12/30 EYEVANCE DISCN 详细信息
ZYLET 050804 001 NDA LOTEPREDNOL ETABONATE; TOBRAMYCIN SUSPENSION/DROPS;OPHTHALMIC 0.5%;0.3% Yes Yes 2004/12/14 BAUSCH AND LOMB RX 详细信息
CHILDREN'S MOTRIN 020603 001 NDA IBUPROFEN SUSPENSION/DROPS;ORAL 40MG/ML Yes Yes 1996/06/10 J AND J CONSUMER INC OTC 详细信息
IBUPROFEN 210755 001 ANDA IBUPROFEN SUSPENSION/DROPS;ORAL 40MG/ML No No 2018/09/26 GUARDIAN DRUG OTC 详细信息
IBUPROFEN 075217 001 ANDA IBUPROFEN SUSPENSION/DROPS;ORAL 40MG/ML No No 1998/12/16 L PERRIGO CO OTC 详细信息
IBUPROFEN 079058 001 ANDA IBUPROFEN SUSPENSION/DROPS;ORAL 40MG/ML No No 2009/08/31 TRIS PHARMA INC OTC 详细信息
ILOSONE 061894 003 ANDA ERYTHROMYCIN ESTOLATE SUSPENSION/DROPS;ORAL EQ 100MG BASE/ML No No Approved Prior to Jan 1, 1982 LILLY DISCN 详细信息
INFANT'S ADVIL 020812 002 NDA IBUPROFEN SUSPENSION/DROPS;ORAL 50MG/1.25ML Yes Yes 2000/01/12 PFIZER OTC 详细信息
MOTRIN 020476 001 NDA IBUPROFEN SUSPENSION/DROPS;ORAL 40MG/ML No No 1995/05/25 MCNEIL DISCN 详细信息
PEDIAMYCIN 062305 002 ANDA ERYTHROMYCIN ETHYLSUCCINATE SUSPENSION/DROPS;ORAL EQ 100MG BASE/2.5ML No No Approved Prior to Jan 1, 1982 ROSS LABS DISCN 详细信息
PEDIATRIC ADVIL 020812 001 NDA IBUPROFEN SUSPENSION/DROPS;ORAL 100MG/2.5ML Yes No 1998/01/30 PFIZER DISCN 详细信息
CASPORYN HC 060613 001 NDA HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE SUSPENSION/DROPS;OTIC 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML Yes Yes AT Approved Prior to Jan 1, 1982 CASPER PHARMA LLC RX 详细信息
CIPRO HC 020805 001 NDA CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE SUSPENSION/DROPS;OTIC EQ 0.2% BASE;1% Yes Yes 1998/02/10 NOVARTIS PHARMS CORP RX 详细信息
CIPRODEX 021537 001 NDA CIPROFLOXACIN; DEXAMETHASONE SUSPENSION/DROPS;OTIC 0.3%;0.1% Yes Yes 2003/07/18 NOVARTIS PHARMS CORP RX 详细信息
COLY-MYCIN S 050356 001 NDA COLISTIN SULFATE; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; THONZONIUM BROMIDE SUSPENSION/DROPS;OTIC EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML Yes Yes Approved Prior to Jan 1, 1982 ENDO PHARMS INC RX 详细信息
NEO-CORT-DOME 050238 001 NDA ACETIC ACID, GLACIAL; HYDROCORTISONE; NEOMYCIN SULFATE SUSPENSION/DROPS;OTIC 2%;1%;EQ 0.35% BASE No No Approved Prior to Jan 1, 1982 BAYER PHARMS DISCN 详细信息
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE 065219 001 ANDA HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE SUSPENSION/DROPS;OTIC 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML No No AT 2006/05/01 AMRING PHARMS RX 详细信息
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE 062488 001 ANDA HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE SUSPENSION/DROPS;OTIC 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML No No AT 1985/11/06 SANDOZ INC RX 详细信息
NEOMYCIN SULFATE, POLYMYXIN B SULFATE & HYDROCORTISONE 062617 001 ANDA HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE SUSPENSION/DROPS;OTIC 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML No No 1985/09/18 PHARMAFAIR DISCN 详细信息
OTICAIR 064065 001 ANDA HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE SUSPENSION/DROPS;OTIC 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML No No AT 1996/08/28 BAUSCH AND LOMB RX 详细信息
当前数据更新日期:2019年10月16日,更多信息请点击此处查询美国FDA药品数据库
数据库说明:本数据与美国FDA官方药品橙皮书数据库同步,在官方数据基础上,提供更全面的检索方式和更简洁高效、完整的数据展现,并且可以回溯专利及市场独占权(市场排他数据)历史信息。
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