美国FDA药品橙皮书数据库
（U.S. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations）
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数据记录共 47588 条，共 2380 页，当前第 62 页
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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
CORDRAN SP 012806 003 NDA FLURANDRENOLIDE CREAM;TOPICAL 0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No Approved Prior to Jan 1, 1982 INA PHARMS DISCN 详细信息
CORDRAN SP 012806 002 NDA FLURANDRENOLIDE CREAM;TOPICAL 0.05% Yes No Approved Prior to Jan 1, 1982 INA PHARMS DISCN 详细信息
CORMAX 074220 001 ANDA CLOBETASOL PROPIONATE CREAM;TOPICAL 0.05% No No 1997/05/16 HIKMA DISCN 详细信息
CORT-DOME 009585 003 NDA HYDROCORTISONE CREAM;TOPICAL 0.5% No No Approved Prior to Jan 1, 1982 BAYER PHARMS DISCN 详细信息
CORT-DOME 009585 001 NDA HYDROCORTISONE CREAM;TOPICAL 1% No No Approved Prior to Jan 1, 1982 BAYER PHARMS DISCN 详细信息
CORTISPORIN 050218 001 NDA HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 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0.5%;EQ 3.5MG BASE/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1985/08/09 MONARCH PHARMS DISCN 详细信息
CUTIVATE 019958 001 NDA FLUTICASONE PROPIONATE CREAM;TOPICAL 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1990/12/18 FOUGERA PHARMS DISCN 详细信息
CYCLOCORT 018116 001 NDA AMCINONIDE CREAM;TOPICAL 0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No Approved Prior to Jan 1, 1982 ASTELLAS DISCN 详细信息
CYCLOCORT 018116 002 NDA AMCINONIDE CREAM;TOPICAL 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No Approved Prior to Jan 1, 1982 ASTELLAS DISCN 详细信息
DECADRON 011983 002 NDA DEXAMETHASONE SODIUM PHOSPHATE CREAM;TOPICAL EQ 0.1% PHOSPHATE No No Approved Prior to Jan 1, 1982 MERCK DISCN 详细信息
DENAVIR 020629 001 NDA PENCICLOVIR CREAM;TOPICAL 1% Yes Yes AB 1996/09/24 MYLAN RX 详细信息
DERMABET 072041 001 ANDA BETAMETHASONE VALERATE CREAM;TOPICAL EQ 0.1% BASE No No AB 1988/01/06 SUN PHARMA CANADA RX 详细信息
DERMACORT 083011 002 ANDA HYDROCORTISONE CREAM;TOPICAL 1% No No Approved Prior to Jan 1, 1982 MONARCH PHARMS DISCN 详细信息
DERMATOP E EMOLLIENT 020279 001 NDA PREDNICARBATE CREAM;TOPICAL 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1993/10/29 VALEANT BERMUDA DISCN 详细信息
DESONIDE 214396 001 ANDA DESONIDE CREAM;TOPICAL 0.05% No No AB 2022/12/08 ALEMBIC RX 详细信息
DESONIDE 210198 001 ANDA DESONIDE CREAM;TOPICAL 0.05% No Yes AB 2019/11/20 CADILA RX 详细信息
DESONIDE 074027 001 ANDA DESONIDE CREAM;TOPICAL 0.05% No No AB 1992/09/28 COSETTE RX 详细信息
DESONIDE 209729 001 ANDA DESONIDE CREAM;TOPICAL 0.05% No No 2017/07/24 GLENMARK SPECLT DISCN 详细信息
DESONIDE 017010 001 NDA DESONIDE CREAM;TOPICAL 0.05% Yes No Approved Prior to Jan 1, 1982 PADAGIS US DISCN 详细信息
DESONIDE 073548 001 ANDA DESONIDE CREAM;TOPICAL 0.05% No No AB 1992/06/30 SUN PHARMA CANADA RX 详细信息
当前数据更新日期：2026年02月10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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