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 52 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
PROCHLORPERAZINE MALEATE 216202 002 ANDA PROCHLORPERAZINE MALEATE TABLET;ORAL EQ 10MG BASE No No AB 2022/06/13 NOVITIUM PHARMA RX 详细信息
PROCHLORPERAZINE MALEATE 040185 002 ANDA PROCHLORPERAZINE MALEATE TABLET;ORAL EQ 5MG BASE No No 1996/10/28 PHARMOBEDIENT DISCN 详细信息
PROCHLORPERAZINE MALEATE 040185 001 ANDA PROCHLORPERAZINE MALEATE TABLET;ORAL EQ 10MG BASE No No 1996/10/28 PHARMOBEDIENT DISCN 详细信息
PROCHLORPERAZINE MALEATE 040120 001 ANDA PROCHLORPERAZINE MALEATE TABLET;ORAL EQ 5MG BASE No No 1996/07/11 TEVA PHARMS DISCN 详细信息
PROCHLORPERAZINE MALEATE 040120 002 ANDA PROCHLORPERAZINE MALEATE TABLET;ORAL EQ 10MG BASE No No 1996/07/11 TEVA PHARMS DISCN 详细信息
PROCHLORPERAZINE MALEATE 216495 001 ANDA PROCHLORPERAZINE MALEATE TABLET;ORAL EQ 5MG BASE No No AB 2022/08/08 ZYDUS LIFESCIENCES RX 详细信息
PROCHLORPERAZINE MALEATE 216495 002 ANDA PROCHLORPERAZINE MALEATE TABLET;ORAL EQ 10MG BASE No No AB 2022/08/08 ZYDUS LIFESCIENCES RX 详细信息
PROCOMP 040268 001 ANDA PROCHLORPERAZINE MALEATE TABLET;ORAL EQ 5MG BASE No No AB 1998/02/27 JUBILANT CADISTA RX 详细信息
PROCOMP 040268 002 ANDA PROCHLORPERAZINE MALEATE TABLET;ORAL EQ 10MG BASE No Yes AB 1998/02/27 JUBILANT CADISTA RX 详细信息
PROKETAZINE 012768 001 NDA CARPHENAZINE MALEATE TABLET;ORAL 12.5MG No No Approved Prior to Jan 1, 1982 WYETH AYERST DISCN 详细信息
PROKETAZINE 012768 002 NDA CARPHENAZINE MALEATE TABLET;ORAL 25MG No No Approved Prior to Jan 1, 1982 WYETH AYERST DISCN 详细信息
PROKETAZINE 012768 004 NDA CARPHENAZINE MALEATE TABLET;ORAL 50MG No No Approved Prior to Jan 1, 1982 WYETH AYERST DISCN 详细信息
PROKLAR 080273 001 ANDA SULFAMETHIZOLE TABLET;ORAL 500MG No No Approved Prior to Jan 1, 1982 FOREST PHARMS DISCN 详细信息
PROLIXIN 011751 004 NDA FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No Approved Prior to Jan 1, 1982 APOTHECON DISCN 详细信息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 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NDA FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No Approved Prior to Jan 1, 1982 APOTHECON DISCN 详细信息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
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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