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 89 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
PROMETHAZINE HYDROCHLORIDE 089463 001 ANDA PROMETHAZINE HYDROCHLORIDE INJECTABLE;INJECTION 25MG/ML No No 1988/05/02 MARSAM PHARMS LLC DISCN 详细信息
PROMETHAZINE HYDROCHLORIDE 089477 001 ANDA PROMETHAZINE HYDROCHLORIDE INJECTABLE;INJECTION 50MG/ML No No 1988/05/02 MARSAM PHARMS LLC DISCN 详细信息
PROMETHAZINE HYDROCHLORIDE 040471 001 ANDA PROMETHAZINE HYDROCHLORIDE INJECTABLE;INJECTION 25MG/ML No No 2002/11/21 MYLAN INSTITUTIONAL DISCN 详细信息
PROMETHAZINE HYDROCHLORIDE 040593 001 ANDA PROMETHAZINE HYDROCHLORIDE INJECTABLE;INJECTION 25MG/ML No No 2006/11/08 SANDOZ DISCN 详细信息
PROMETHAZINE HYDROCHLORIDE 040593 002 ANDA PROMETHAZINE HYDROCHLORIDE INJECTABLE;INJECTION 50MG/ML No No 2006/11/08 SANDOZ DISCN 详细信息
PROMETHAZINE HYDROCHLORIDE 040454 001 ANDA PROMETHAZINE HYDROCHLORIDE INJECTABLE;INJECTION 25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** No No 2002/08/22 TEVA PHARMS USA DISCN 详细信息
PROMETHAZINE HYDROCHLORIDE 040454 002 ANDA PROMETHAZINE HYDROCHLORIDE INJECTABLE;INJECTION 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** No No 2002/08/22 TEVA PHARMS USA DISCN 详细信息
PROMETHAZINE HYDROCHLORIDE 083532 001 ANDA PROMETHAZINE HYDROCHLORIDE INJECTABLE;INJECTION 25MG/ML No No Approved Prior to Jan 1, 1982 WATSON LABS DISCN 详细信息
PROMETHAZINE HYDROCHLORIDE 084591 001 ANDA PROMETHAZINE HYDROCHLORIDE INJECTABLE;INJECTION 25MG/ML No No Approved Prior to Jan 1, 1982 WATSON LABS DISCN 详细信息
PROMETHAZINE HYDROCHLORIDE 080629 002 ANDA PROMETHAZINE HYDROCHLORIDE INJECTABLE;INJECTION 50MG/ML No No Approved Prior to Jan 1, 1982 WATSON LABS DISCN 详细信息
PROMETHAZINE HYDROCHLORIDE 083532 002 ANDA PROMETHAZINE HYDROCHLORIDE INJECTABLE;INJECTION 50MG/ML No No Approved Prior to Jan 1, 1982 WATSON LABS DISCN 详细信息
PROMETHAZINE HYDROCHLORIDE 040785 001 ANDA PROMETHAZINE HYDROCHLORIDE INJECTABLE;INJECTION 25MG/ML No No 2008/09/26 WOCKHARDT BIO AG DISCN 详细信息
PROMETHAZINE HYDROCHLORIDE 040785 002 ANDA PROMETHAZINE HYDROCHLORIDE INJECTABLE;INJECTION 50MG/ML No No 2008/09/26 WOCKHARDT BIO AG DISCN 详细信息
PROMETHAZINE HYDROCHLORIDE 040737 001 ANDA PROMETHAZINE HYDROCHLORIDE INJECTABLE;INJECTION 25MG/ML No No AP 2008/04/24 XGEN PHARMS RX 详细信息
PROMETHAZINE HYDROCHLORIDE 040737 002 ANDA PROMETHAZINE HYDROCHLORIDE INJECTABLE;INJECTION 50MG/ML No No AP 2008/04/24 XGEN PHARMS RX 详细信息
PRONESTYL 007335 002 NDA PROCAINAMIDE HYDROCHLORIDE INJECTABLE;INJECTION 100MG/ML **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
PRONESTYL 007335 005 NDA PROCAINAMIDE HYDROCHLORIDE INJECTABLE;INJECTION 500MG/ML **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
PROPOFOL 217525 001 ANDA PROPOFOL INJECTABLE;INJECTION 10MG/ML No No AB 2024/08/15 AMNEAL RX 详细信息
PROPOFOL 217013 001 ANDA PROPOFOL INJECTABLE;INJECTION 10MG/ML No No AB 2024/06/20 ASPIRO RX 详细信息
PROPOFOL 206408 001 ANDA PROPOFOL INJECTABLE;INJECTION 10MG/ML No No AB 2021/10/12 AVET LIFESCIENCES RX 详细信息
当前数据更新日期：2026年06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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