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 47588 条，共 2380 页，当前第 54 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
SERTRALINE HYDROCHLORIDE 076934 001 ANDA SERTRALINE HYDROCHLORIDE CONCENTRATE;ORAL EQ 20MG BASE/ML No No AA 2006/06/30 STRIDES PHARMA RX 详细信息
SINEQUAN 017516 001 NDA DOXEPIN HYDROCHLORIDE CONCENTRATE;ORAL EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No Approved Prior to Jan 1, 1982 PFIZER DISCN 详细信息
SONAZINE 080983 004 ANDA CHLORPROMAZINE HYDROCHLORIDE CONCENTRATE;ORAL 30MG/ML No No Approved Prior to Jan 1, 1982 SAPTALIS PHARMS DISCN 详细信息
SONAZINE 080983 005 ANDA CHLORPROMAZINE HYDROCHLORIDE CONCENTRATE;ORAL 100MG/ML No No Approved Prior to Jan 1, 1982 SAPTALIS PHARMS DISCN 详细信息
SPARINE 010942 001 NDA PROMAZINE HYDROCHLORIDE CONCENTRATE;ORAL 30MG/ML No No Approved Prior to Jan 1, 1982 WYETH AYERST DISCN 详细信息
SPARINE 010942 004 NDA PROMAZINE HYDROCHLORIDE CONCENTRATE;ORAL 100MG/ML No No Approved Prior to Jan 1, 1982 WYETH AYERST DISCN 详细信息
STELAZINE 011552 006 NDA TRIFLUOPERAZINE HYDROCHLORIDE CONCENTRATE;ORAL EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No Approved Prior to Jan 1, 1982 GLAXOSMITHKLINE DISCN 详细信息
TARACTAN 016149 002 NDA CHLORPROTHIXENE CONCENTRATE;ORAL 100MG/5ML No No Approved Prior to Jan 1, 1982 ROCHE DISCN 详细信息
THIORIDAZINE HYDROCHLORIDE 088229 001 ANDA THIORIDAZINE HYDROCHLORIDE CONCENTRATE;ORAL 100MG/ML No No 1983/08/23 ACTAVIS MID ATLANTIC DISCN 详细信息
THIORIDAZINE HYDROCHLORIDE 087766 001 ANDA THIORIDAZINE HYDROCHLORIDE CONCENTRATE;ORAL 30MG/ML No No 1983/04/26 ALPHARMA US PHARMS DISCN 详细信息
THIORIDAZINE HYDROCHLORIDE 089602 001 ANDA THIORIDAZINE HYDROCHLORIDE CONCENTRATE;ORAL 30MG/ML No No 1987/11/09 ANI PHARMS DISCN 详细信息
THIORIDAZINE HYDROCHLORIDE 089603 001 ANDA THIORIDAZINE HYDROCHLORIDE CONCENTRATE;ORAL 100MG/ML No No 1987/11/09 ANI PHARMS DISCN 详细信息
THIORIDAZINE HYDROCHLORIDE 040125 001 ANDA THIORIDAZINE HYDROCHLORIDE CONCENTRATE;ORAL 30MG/ML No No 1996/08/16 EPIC PHARMA LLC DISCN 详细信息
THIORIDAZINE HYDROCHLORIDE 040126 001 ANDA THIORIDAZINE HYDROCHLORIDE CONCENTRATE;ORAL 100MG/ML No No 1996/08/16 EPIC PHARMA LLC DISCN 详细信息
THIORIDAZINE HYDROCHLORIDE 040187 001 ANDA THIORIDAZINE HYDROCHLORIDE CONCENTRATE;ORAL 30MG/ML No No 1997/08/28 PHARM ASSOC DISCN 详细信息
THIORIDAZINE HYDROCHLORIDE 040213 001 ANDA THIORIDAZINE HYDROCHLORIDE CONCENTRATE;ORAL 100MG/ML No No 1998/05/29 PHARM ASSOC DISCN 详细信息
THIORIDAZINE HYDROCHLORIDE 088307 001 ANDA THIORIDAZINE HYDROCHLORIDE CONCENTRATE;ORAL 30MG/ML No No 1983/11/23 SANDOZ DISCN 详细信息
THIORIDAZINE HYDROCHLORIDE 088308 001 ANDA THIORIDAZINE HYDROCHLORIDE CONCENTRATE;ORAL 100MG/ML No No 1983/11/23 SANDOZ DISCN 详细信息
THIORIDAZINE HYDROCHLORIDE 088258 001 ANDA THIORIDAZINE HYDROCHLORIDE CONCENTRATE;ORAL 30MG/ML No No 1983/07/25 WOCKHARDT DISCN 详细信息
THIORIDAZINE HYDROCHLORIDE 088227 001 ANDA THIORIDAZINE HYDROCHLORIDE CONCENTRATE;ORAL 100MG/ML No No 1983/07/05 WOCKHARDT 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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