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 73 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
IVERMECTIN 215210 001 ANDA IVERMECTIN CREAM;TOPICAL 1% No No AB 2022/08/02 ZYDUS LIFESCIENCES RX 详细信息
KENALOG 083943 001 ANDA TRIAMCINOLONE ACETONIDE CREAM;TOPICAL 0.5% Yes No Approved Prior to Jan 1, 1982 DELCOR ASSET CORP DISCN 详细信息
KENALOG-H 086240 001 ANDA TRIAMCINOLONE ACETONIDE CREAM;TOPICAL 0.1% No No Approved Prior to Jan 1, 1982 DELCOR ASSET CORP DISCN 详细信息
KETOCONAZOLE 212443 001 ANDA KETOCONAZOLE CREAM;TOPICAL 2% No Yes AB 2021/05/20 ENCUBE RX 详细信息
KETOCONAZOLE 076294 001 ANDA KETOCONAZOLE CREAM;TOPICAL 2% No No AB 2004/04/28 FOUGERA PHARMS RX 详细信息
KETOCONAZOLE 215185 001 ANDA KETOCONAZOLE CREAM;TOPICAL 2% No No AB 2021/11/17 PADAGIS US RX 详细信息
KETOCONAZOLE 075581 001 ANDA KETOCONAZOLE CREAM;TOPICAL 2% No No AB 2000/04/25 TEVA RX 详细信息
KETOZOLE 075638 001 ANDA KETOCONAZOLE CREAM;TOPICAL 2% No No AB 2002/12/18 SUN PHARMA CANADA RX 详细信息
KWELL 084218 001 ANDA LINDANE CREAM;TOPICAL 1% No No Approved Prior to Jan 1, 1982 REED AND CARNRICK DISCN 详细信息
KWELL 006309 001 NDA LINDANE CREAM;TOPICAL 1% No No Approved Prior to Jan 1, 1982 REED AND CARNRICK DISCN 详细信息
LAC-HYDRIN 020508 001 NDA AMMONIUM LACTATE CREAM;TOPICAL EQ 12% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1996/08/29 SUN PHARM INDS INC DISCN 详细信息
LAMISIL 020980 001 NDA TERBINAFINE HYDROCHLORIDE CREAM;TOPICAL 1% Yes Yes 1999/03/09 KARO HLTHCARE OTC 详细信息
LAMISIL 020192 001 NDA TERBINAFINE HYDROCHLORIDE CREAM;TOPICAL 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** No No 1992/12/30 NOVARTIS DISCN 详细信息
LIDEX 016908 002 NDA FLUOCINONIDE CREAM;TOPICAL 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No Approved Prior to Jan 1, 1982 ALVOGEN DISCN 详细信息
LIDEX-E 016908 003 NDA FLUOCINONIDE CREAM;TOPICAL 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No Approved Prior to Jan 1, 1982 ALVOGEN DISCN 详细信息
LIDOCAINE AND PRILOCAINE 213923 001 ANDA LIDOCAINE; PRILOCAINE CREAM;TOPICAL 2.5%;2.5% No No AB 2022/04/08 ALEMBIC RX 详细信息
LIDOCAINE AND PRILOCAINE 213253 001 ANDA LIDOCAINE; PRILOCAINE CREAM;TOPICAL 2.5%;2.5% No No 2020/09/21 CHARTWELL RX DISCN 详细信息
LIDOCAINE AND PRILOCAINE 076320 001 ANDA LIDOCAINE; PRILOCAINE CREAM;TOPICAL 2.5%;2.5% No No AB 2003/08/27 ENCUBE RX 详细信息
LIDOCAINE AND PRILOCAINE 076453 001 ANDA LIDOCAINE; PRILOCAINE CREAM;TOPICAL 2.5%;2.5% No Yes AB 2003/08/18 FOUGERA PHARMS RX 详细信息
LIDOCAINE AND PRILOCAINE 076290 001 ANDA LIDOCAINE; PRILOCAINE CREAM;TOPICAL 2.5%;2.5% No No 2003/09/25 HIKMA DISCN 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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