美国FDA药品橙皮书数据库
（U.S. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations）
请输入需要查询的英文药品商品名，活性成分，申请号
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数据记录共 47588 条，共 2380 页，当前第 44 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
PROLIXIN 011751 001 NDA FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No Approved Prior to Jan 1, 1982 APOTHECON DISCN 详细信息
PROLIXIN 011751 003 NDA FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No Approved Prior to Jan 1, 1982 APOTHECON DISCN 详细信息
PROLIXIN 011751 002 NDA FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No Approved Prior to Jan 1, 1982 APOTHECON DISCN 详细信息
PROLOPRIM 017943 001 NDA TRIMETHOPRIM TABLET;ORAL 100MG No No Approved Prior to Jan 1, 1982 MONARCH PHARMS DISCN 详细信息
PROLOPRIM 017943 003 NDA TRIMETHOPRIM TABLET;ORAL 200MG No No 1982/07/14 MONARCH PHARMS DISCN 详细信息
PROMACTA 022291 004 NDA ELTROMBOPAG OLAMINE TABLET;ORAL EQ 12.5MG ACID Yes No AB 2011/10/20 NOVARTIS RX 详细信息
PROMACTA 022291 001 NDA ELTROMBOPAG OLAMINE TABLET;ORAL EQ 25MG ACID Yes No AB 2008/11/20 NOVARTIS RX 详细信息
PROMACTA 022291 002 NDA ELTROMBOPAG OLAMINE TABLET;ORAL EQ 50MG ACID Yes No AB 2008/11/20 NOVARTIS RX 详细信息
PROMACTA 022291 003 NDA ELTROMBOPAG OLAMINE TABLET;ORAL EQ 75MG ACID Yes Yes AB 2009/09/08 NOVARTIS RX 详细信息
PROMACTA 022291 005 NDA ELTROMBOPAG OLAMINE TABLET;ORAL EQ 100MG ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2012/11/16 NOVARTIS DISCN 详细信息
PROMAPAR 086886 001 ANDA CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 10MG No No Approved Prior to Jan 1, 1982 PARKE DAVIS DISCN 详细信息
PROMAPAR 084423 001 ANDA CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 25MG No No Approved Prior to Jan 1, 1982 PARKE DAVIS DISCN 详细信息
PROMAPAR 086887 001 ANDA CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 50MG No No Approved Prior to Jan 1, 1982 PARKE DAVIS DISCN 详细信息
PROMAPAR 086888 001 ANDA CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 100MG No No Approved Prior to Jan 1, 1982 PARKE DAVIS DISCN 详细信息
PROMAPAR 086885 001 ANDA CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 200MG No No Approved Prior to Jan 1, 1982 PARKE DAVIS DISCN 详细信息
PROMETHAZINE HYDROCHLORIDE 084160 001 ANDA PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 12.5MG No No Approved Prior to Jan 1, 1982 ABBOTT DISCN 详细信息
PROMETHAZINE HYDROCHLORIDE 084166 001 ANDA PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 25MG No No Approved Prior to Jan 1, 1982 ABBOTT DISCN 详细信息
PROMETHAZINE HYDROCHLORIDE 084539 001 ANDA PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 50MG No No Approved Prior to Jan 1, 1982 ABBOTT DISCN 详细信息
PROMETHAZINE HYDROCHLORIDE 040558 001 ANDA PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 12.5MG No No 2004/07/01 ABLE DISCN 详细信息
PROMETHAZINE HYDROCHLORIDE 040558 002 ANDA PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 25MG No No 2004/07/01 ABLE 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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