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 49 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
PRIMIDONE 040626 002 ANDA PRIMIDONE TABLET;ORAL 250MG No No AB 2005/09/29 TP ANDA HOLDINGS RX 详细信息
PRIMIDONE 083551 001 ANDA PRIMIDONE TABLET;ORAL 250MG No No AB Approved Prior to Jan 1, 1982 WATSON LABS RX 详细信息
PRIMIDONE 085052 001 ANDA PRIMIDONE TABLET;ORAL 250MG No No Approved Prior to Jan 1, 1982 WATSON LABS DISCN 详细信息
PRINIVIL 019558 006 NDA LISINOPRIL TABLET;ORAL 2.5MG No No 1994/01/28 MERCK DISCN 详细信息
PRINIVIL 019558 001 NDA LISINOPRIL TABLET;ORAL 5MG No No 1987/12/29 MERCK DISCN 详细信息
PRINIVIL 019558 002 NDA LISINOPRIL TABLET;ORAL 10MG No No 1987/12/29 MERCK DISCN 详细信息
PRINIVIL 019558 003 NDA LISINOPRIL TABLET;ORAL 20MG No No 1987/12/29 MERCK DISCN 详细信息
PRINIVIL 019558 004 NDA LISINOPRIL TABLET;ORAL 40MG No No 1988/10/25 MERCK DISCN 详细信息
PRINZIDE 019778 003 NDA HYDROCHLOROTHIAZIDE; LISINOPRIL TABLET;ORAL 12.5MG;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1993/11/18 MERCK DISCN 详细信息
PRINZIDE 019778 001 NDA HYDROCHLOROTHIAZIDE; LISINOPRIL TABLET;ORAL 12.5MG;20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1989/02/16 MERCK DISCN 详细信息
PRINZIDE 019778 002 NDA HYDROCHLOROTHIAZIDE; LISINOPRIL TABLET;ORAL 25MG;20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1989/02/16 MERCK DISCN 详细信息
PRO-BANTHINE 008732 003 NDA PROPANTHELINE BROMIDE TABLET;ORAL 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No Approved Prior to Jan 1, 1982 SHIRE DISCN 详细信息
PRO-BANTHINE 008732 002 NDA PROPANTHELINE BROMIDE TABLET;ORAL 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No Approved Prior to Jan 1, 1982 SHIRE DISCN 详细信息
PROAMATINE 019815 001 NDA MIDODRINE HYDROCHLORIDE TABLET;ORAL 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1996/09/06 TAKEDA PHARMS USA DISCN 详细信息
PROAMATINE 019815 002 NDA MIDODRINE HYDROCHLORIDE TABLET;ORAL 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1996/09/06 TAKEDA PHARMS USA DISCN 详细信息
PROAMATINE 019815 003 NDA MIDODRINE HYDROCHLORIDE TABLET;ORAL 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2002/03/20 TAKEDA PHARMS USA DISCN 详细信息
PROBALAN 080966 001 ANDA PROBENECID TABLET;ORAL 500MG No No AB Approved Prior to Jan 1, 1982 LANNETT RX 详细信息
PROBEN-C 085552 001 ANDA COLCHICINE; PROBENECID TABLET;ORAL 0.5MG;500MG No No Approved Prior to Jan 1, 1982 WATSON LABS DISCN 详细信息
PROBENECID 084211 002 ANDA PROBENECID TABLET;ORAL 500MG No No Approved Prior to Jan 1, 1982 AUROBINDO PHARMA USA DISCN 详细信息
PROBENECID 083740 001 ANDA PROBENECID TABLET;ORAL 500MG No No 1984/05/09 IVAX SUB TEVA PHARMS 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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