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 45108 条，共 2256 页，当前第 1 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
PROPYLTHIOURACIL 083982 001 ANDA PROPYLTHIOURACIL TABLET;ORAL 50MG No No Approved Prior to Jan 1, 1982 SUN PHARM INDUSTRIES DISCN 详细信息
PROPYLTHIOURACIL 080840 001 ANDA PROPYLTHIOURACIL TABLET;ORAL 50MG No No Approved Prior to Jan 1, 1982 TABLICAPS DISCN 详细信息
PROPYLTHIOURACIL 080932 001 ANDA PROPYLTHIOURACIL TABLET;ORAL 50MG No No Approved Prior to Jan 1, 1982 WATSON LABS DISCN 详细信息
PROPYLTHIOURACIL 085201 001 ANDA PROPYLTHIOURACIL TABLET;ORAL 50MG No No Approved Prior to Jan 1, 1982 WATSON LABS DISCN 详细信息
PROSCAR 020180 001 NDA FINASTERIDE TABLET;ORAL 5MG Yes Yes AB 1992/06/19 ORGANON RX 详细信息
PROSOM 019080 001 NDA ESTAZOLAM TABLET;ORAL 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1990/12/26 ABBOTT DISCN 详细信息
PROSOM 019080 002 NDA ESTAZOLAM TABLET;ORAL 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1990/12/26 ABBOTT DISCN 详细信息
PROTOPAM CHLORIDE 014122 002 NDA PRALIDOXIME CHLORIDE TABLET;ORAL 500MG No No Approved Prior to Jan 1, 1982 WYETH AYERST DISCN 详细信息
PROTOSTAT 018871 001 NDA METRONIDAZOLE TABLET;ORAL 250MG No No 1983/03/02 ORTHO MCNEIL PHARM DISCN 详细信息
PROTOSTAT 018871 002 NDA METRONIDAZOLE TABLET;ORAL 500MG No No 1983/03/02 ORTHO MCNEIL PHARM DISCN 详细信息
PROTRIPTYLINE HYDROCHLORIDE 202220 001 ANDA PROTRIPTYLINE HYDROCHLORIDE TABLET;ORAL 5MG No No AB 2012/11/19 EPIC PHARMA LLC RX 详细信息
PROTRIPTYLINE HYDROCHLORIDE 202220 002 ANDA PROTRIPTYLINE HYDROCHLORIDE TABLET;ORAL 10MG No No AB 2012/11/19 EPIC PHARMA LLC RX 详细信息
PROTRIPTYLINE HYDROCHLORIDE 078913 001 ANDA PROTRIPTYLINE HYDROCHLORIDE TABLET;ORAL 5MG No No AB 2008/09/16 HIKMA RX 详细信息
PROTRIPTYLINE HYDROCHLORIDE 078913 002 ANDA PROTRIPTYLINE HYDROCHLORIDE TABLET;ORAL 10MG No Yes AB 2008/09/16 HIKMA RX 详细信息
PROTRIPTYLINE HYDROCHLORIDE 090462 001 ANDA PROTRIPTYLINE HYDROCHLORIDE TABLET;ORAL 5MG No No AB 2010/05/03 SIGMAPHARM LABS LLC RX 详细信息
PROTRIPTYLINE HYDROCHLORIDE 090462 002 ANDA PROTRIPTYLINE HYDROCHLORIDE TABLET;ORAL 10MG No No AB 2010/05/03 SIGMAPHARM LABS LLC RX 详细信息
PROVENTIL 017853 001 NDA ALBUTEROL SULFATE TABLET;ORAL EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1982/05/07 SCHERING DISCN 详细信息
PROVENTIL 017853 002 NDA ALBUTEROL SULFATE TABLET;ORAL EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1982/05/07 SCHERING DISCN 详细信息
PROVERA 011839 001 NDA MEDROXYPROGESTERONE ACETATE TABLET;ORAL 2.5MG Yes No AB Approved Prior to Jan 1, 1982 PFIZER RX 详细信息
PROVERA 011839 003 NDA MEDROXYPROGESTERONE ACETATE TABLET;ORAL 5MG Yes No AB Approved Prior to Jan 1, 1982 PFIZER RX 详细信息
当前数据更新日期：2024年06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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