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 14 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
CARBIDOPA AND LEVODOPA 078690 003 ANDA CARBIDOPA; LEVODOPA TABLET, ORALLY DISINTEGRATING;ORAL 25MG;250MG No Yes AB 2009/07/31 SUN PHARM RX 详细信息
CETIRIZINE HYDROCHLORIDE 213557 001 ANDA CETIRIZINE HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING;ORAL 10MG No No 2020/09/11 AUROBINDO PHARMA LTD OTC 详细信息
CETIRIZINE HYDROCHLORIDE ALLERGY 205490 001 ANDA CETIRIZINE HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING;ORAL 10MG No No 2015/09/02 PERRIGO R AND D OTC 详细信息
CHILDREN'S ALLEGRA ALLERGY 021909 002 NDA FEXOFENADINE HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING;ORAL 30MG Yes No 2011/01/24 CHATTEM SANOFI DISCN 详细信息
CHILDREN'S ALLEGRA HIVES 021909 003 NDA FEXOFENADINE HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING;ORAL 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2011/01/24 CHATTEM SANOFI DISCN 详细信息
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 202978 001 ANDA FEXOFENADINE HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING;ORAL 30MG No No 2013/01/18 DR REDDYS LABS LTD DISCN 详细信息
CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 202978 002 ANDA FEXOFENADINE HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING;ORAL 30MG No No 2013/01/18 DR REDDYS LABS LTD DISCN 详细信息
CITALOPRAM HYDROBROMIDE 021763 001 NDA CITALOPRAM HYDROBROMIDE TABLET, ORALLY DISINTEGRATING;ORAL EQ 10MG BASE Yes No 2005/12/20 BIOVAIL LABS INTL DISCN 详细信息
CITALOPRAM HYDROBROMIDE 021763 002 NDA CITALOPRAM HYDROBROMIDE TABLET, ORALLY DISINTEGRATING;ORAL EQ 20MG BASE Yes No 2005/12/20 BIOVAIL LABS INTL DISCN 详细信息
CITALOPRAM HYDROBROMIDE 021763 003 NDA CITALOPRAM HYDROBROMIDE TABLET, ORALLY DISINTEGRATING;ORAL EQ 40MG BASE Yes No 2005/12/20 BIOVAIL LABS INTL DISCN 详细信息
CLARINEX 021312 002 NDA DESLORATADINE TABLET, ORALLY DISINTEGRATING;ORAL 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2005/07/14 ORGANON DISCN 详细信息
CLARINEX 021312 001 NDA DESLORATADINE TABLET, ORALLY DISINTEGRATING;ORAL 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2002/06/26 ORGANON DISCN 详细信息
CLARITIN HIVES RELIEF REDITAB 020704 003 NDA LORATADINE TABLET, ORALLY DISINTEGRATING;ORAL 10MG Yes Yes 2003/11/19 BAYER HEALTHCARE LLC OTC 详细信息
CLARITIN REDITABS 021993 001 NDA LORATADINE TABLET, ORALLY DISINTEGRATING;ORAL 5MG Yes Yes 2006/12/12 BAYER HEALTHCARE LLC OTC 详细信息
CLARITIN REDITABS 020704 002 NDA LORATADINE TABLET, ORALLY DISINTEGRATING;ORAL 10MG Yes Yes 2002/11/27 BAYER HEALTHCARE LLC OTC 详细信息
CLONAZEPAM 211033 001 ANDA CLONAZEPAM TABLET, ORALLY DISINTEGRATING;ORAL 0.125MG No No AB 2019/06/28 ALEMBIC RX 详细信息
CLONAZEPAM 211033 002 ANDA CLONAZEPAM TABLET, ORALLY DISINTEGRATING;ORAL 0.25MG No No AB 2019/06/28 ALEMBIC RX 详细信息
CLONAZEPAM 211033 003 ANDA CLONAZEPAM TABLET, ORALLY DISINTEGRATING;ORAL 0.5MG No No AB 2019/06/28 ALEMBIC RX 详细信息
CLONAZEPAM 211033 004 ANDA CLONAZEPAM TABLET, ORALLY DISINTEGRATING;ORAL 1MG No No AB 2019/06/28 ALEMBIC RX 详细信息
CLONAZEPAM 211033 005 ANDA CLONAZEPAM TABLET, ORALLY DISINTEGRATING;ORAL 2MG No No AB 2019/06/28 ALEMBIC RX 详细信息
当前数据更新日期：2026年05月23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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