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 48215 条，共 2411 页，当前第 57 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
CONJUGATED ESTROGENS 214023 002 ANDA ESTROGENS, CONJUGATED TABLET;ORAL 1.25MG No No AB 2025/10/15 NOVAST LABS RX 详细信息
CONJUPRI 212895 001 NDA LEVAMLODIPINE MALEATE TABLET;ORAL EQ 1.25MG BASE Yes No 2019/12/19 CSPC OUYI DISCN 详细信息
CONJUPRI 212895 002 NDA LEVAMLODIPINE MALEATE TABLET;ORAL EQ 2.5MG BASE Yes No 2019/12/19 CSPC OUYI DISCN 详细信息
CONJUPRI 212895 003 NDA LEVAMLODIPINE MALEATE TABLET;ORAL EQ 5MG BASE Yes No 2019/12/19 CSPC OUYI DISCN 详细信息
CONSENSI 210045 001 NDA AMLODIPINE BESYLATE; CELECOXIB TABLET;ORAL EQ 2.5MG BASE;200MG Yes No 2018/05/31 PURPLE BIOTECH DISCN 详细信息
CONSENSI 210045 002 NDA AMLODIPINE BESYLATE; CELECOXIB TABLET;ORAL EQ 5MG BASE;200MG Yes No 2018/05/31 PURPLE BIOTECH DISCN 详细信息
CONSENSI 210045 003 NDA AMLODIPINE BESYLATE; CELECOXIB TABLET;ORAL EQ 10MG BASE;200MG Yes No 2018/05/31 PURPLE BIOTECH DISCN 详细信息
COPEGUS 021511 001 NDA RIBAVIRIN TABLET;ORAL 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2002/12/03 ROCHE DISCN 详细信息
COPEGUS 021511 002 NDA RIBAVIRIN TABLET;ORAL 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2005/06/21 ROCHE DISCN 详细信息
CORDARONE 018972 001 NDA AMIODARONE HYDROCHLORIDE TABLET;ORAL 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1985/12/24 WYETH PHARMS DISCN 详细信息
COREG 020297 004 NDA CARVEDILOL TABLET;ORAL 3.125MG Yes No AB 1997/05/29 WAYLIS THERAP RX 详细信息
COREG 020297 003 NDA CARVEDILOL TABLET;ORAL 6.25MG Yes No AB 1995/09/14 WAYLIS THERAP RX 详细信息
COREG 020297 002 NDA CARVEDILOL TABLET;ORAL 12.5MG Yes Yes AB 1995/09/14 WAYLIS THERAP RX 详细信息
COREG 020297 001 NDA CARVEDILOL TABLET;ORAL 25MG Yes No AB 1995/09/14 WAYLIS THERAP RX 详细信息
CORGARD 018063 005 NDA NADOLOL TABLET;ORAL 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1986/10/28 USWM DISCN 详细信息
CORGARD 018063 001 NDA NADOLOL TABLET;ORAL 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No Approved Prior to Jan 1, 1982 USWM DISCN 详细信息
CORGARD 018063 002 NDA NADOLOL TABLET;ORAL 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No Approved Prior to Jan 1, 1982 USWM DISCN 详细信息
CORGARD 018063 003 NDA NADOLOL TABLET;ORAL 120MG No No Approved Prior to Jan 1, 1982 USWM DISCN 详细信息
CORGARD 018063 004 NDA NADOLOL TABLET;ORAL 160MG No No Approved Prior to Jan 1, 1982 USWM DISCN 详细信息
CORLANOR 206143 001 NDA IVABRADINE HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE Yes No 2015/04/15 AMGEN INC DISCN 详细信息
当前数据更新日期：2026年05月27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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