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
*Search by Trade Name,Active Ingredient,Application Number.
高级搜索
数据记录共 47588 条，共 2380 页，当前第 53 页
可点击列名称排序
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
METHADONE HYDROCHLORIDE 212093 001 ANDA METHADONE HYDROCHLORIDE CONCENTRATE;ORAL 10MG/ML No No AA 2020/11/02 LANNETT CO INC RX 详细信息
METHADONE HYDROCHLORIDE 212094 001 ANDA METHADONE HYDROCHLORIDE CONCENTRATE;ORAL 10MG/ML No No 2021/03/03 LANNETT CO INC DISCN 详细信息
METHADONE HYDROCHLORIDE 207368 001 ANDA METHADONE HYDROCHLORIDE CONCENTRATE;ORAL 10MG/ML No No AA 2019/08/22 SPECGX LLC RX 详细信息
METHADONE HYDROCHLORIDE 040088 001 ANDA METHADONE HYDROCHLORIDE CONCENTRATE;ORAL 10MG/ML No No AA 1994/11/30 VISTAPHARM LLC RX 详细信息
METHADONE HYDROCHLORIDE INTENSOL 089897 001 ANDA METHADONE HYDROCHLORIDE CONCENTRATE;ORAL 10MG/ML No No AA 1988/09/06 HIKMA RX 详细信息
METHADOSE 017116 002 NDA METHADONE HYDROCHLORIDE CONCENTRATE;ORAL 10MG/ML Yes Yes AA Approved Prior to Jan 1, 1982 SPECGX LLC RX 详细信息
METOCLOPRAMIDE INTENSOL 072995 001 ANDA METOCLOPRAMIDE HYDROCHLORIDE CONCENTRATE;ORAL EQ 10MG BASE/ML No No 1992/01/30 ROXANE DISCN 详细信息
MOBAN 017938 001 NDA MOLINDONE HYDROCHLORIDE CONCENTRATE;ORAL 20MG/ML No No Approved Prior to Jan 1, 1982 ENDO PHARMS DISCN 详细信息
NAVANE 016758 001 NDA THIOTHIXENE HYDROCHLORIDE CONCENTRATE;ORAL EQ 5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No Approved Prior to Jan 1, 1982 PFIZER DISCN 详细信息
ORLAAM 020315 001 NDA LEVOMETHADYL ACETATE HYDROCHLORIDE CONCENTRATE;ORAL 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1993/07/09 ROXANE DISCN 详细信息
PERMITIL 016008 001 NDA FLUPHENAZINE HYDROCHLORIDE CONCENTRATE;ORAL 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** No No Approved Prior to Jan 1, 1982 SCHERING DISCN 详细信息
PERPHENAZINE 040360 001 ANDA PERPHENAZINE CONCENTRATE;ORAL 16MG/5ML No No 2001/05/25 PHARM ASSOC DISCN 详细信息
PROCHLORPERAZINE 087153 001 ANDA PROCHLORPERAZINE EDISYLATE CONCENTRATE;ORAL EQ 10MG BASE/ML No No 1982/06/08 ALPHARMA US PHARMS DISCN 详细信息
PROCHLORPERAZINE EDISYLATE 088598 001 ANDA PROCHLORPERAZINE EDISYLATE CONCENTRATE;ORAL EQ 10MG BASE/ML No No 1984/10/25 MORTON GROVE DISCN 详细信息
PROKETAZINE 014173 001 NDA CARPHENAZINE MALEATE CONCENTRATE;ORAL 50MG/ML No No Approved Prior to Jan 1, 1982 WYETH AYERST DISCN 详细信息
PROLIXIN 070533 001 ANDA FLUPHENAZINE HYDROCHLORIDE CONCENTRATE;ORAL 5MG/ML No No 1985/11/07 APOTHECON DISCN 详细信息
PROPRANOLOL HYDROCHLORIDE INTENSOL 071388 001 ANDA PROPRANOLOL HYDROCHLORIDE CONCENTRATE;ORAL 80MG/ML No No 1987/05/15 ROXANE DISCN 详细信息
SERENTIL 016997 001 NDA MESORIDAZINE BESYLATE CONCENTRATE;ORAL EQ 25MG BASE/ML No No Approved Prior to Jan 1, 1982 NOVARTIS DISCN 详细信息
SERTRALINE HYDROCHLORIDE 078861 001 ANDA SERTRALINE HYDROCHLORIDE CONCENTRATE;ORAL EQ 20MG BASE/ML No No AA 2008/10/31 AUROBINDO PHARMA RX 详细信息
SERTRALINE HYDROCHLORIDE 078053 001 ANDA SERTRALINE HYDROCHLORIDE CONCENTRATE;ORAL EQ 20MG BASE/ML No No 2007/02/05 RANBAXY LABS LTD 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。
©2006-2026 DrugFuture->U.S. FDA Orange Book