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 56 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 083401 001 ANDA PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 12.5MG No No Approved Prior to Jan 1, 1982 WATSON LABS DISCN 详细信息
PROMETHAZINE HYDROCHLORIDE 083712 001 ANDA PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 12.5MG No No Approved Prior to Jan 1, 1982 WATSON LABS DISCN 详细信息
PROMETHAZINE HYDROCHLORIDE 085986 001 ANDA PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 12.5MG No No Approved Prior to Jan 1, 1982 WATSON LABS DISCN 详细信息
PROMETHAZINE HYDROCHLORIDE 083204 001 ANDA PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 25MG No No Approved Prior to Jan 1, 1982 WATSON LABS DISCN 详细信息
PROMETHAZINE HYDROCHLORIDE 083426 001 ANDA PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 25MG No No AB Approved Prior to Jan 1, 1982 WATSON LABS RX 详细信息
PROMETHAZINE HYDROCHLORIDE 085684 001 ANDA PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 25MG No No Approved Prior to Jan 1, 1982 WATSON LABS DISCN 详细信息
PROMETHAZINE HYDROCHLORIDE 083403 001 ANDA PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 50MG No No Approved Prior to Jan 1, 1982 WATSON LABS DISCN 详细信息
PROMETHAZINE HYDROCHLORIDE 083711 001 ANDA PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 50MG No No AB Approved Prior to Jan 1, 1982 WATSON LABS RX 详细信息
PROMETHAZINE HYDROCHLORIDE 085664 001 ANDA PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 50MG No No Approved Prior to Jan 1, 1982 WATSON LABS DISCN 详细信息
PROMETHAZINE HYDROCHLORIDE 040596 001 ANDA PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 12.5MG No No AB 2005/11/18 ZYDUS PHARMS USA RX 详细信息
COMBUNOX 021378 001 NDA IBUPROFEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 400MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2004/11/26 FOREST LABS DISCN 详细信息
COMPAZINE 010571 001 NDA PROCHLORPERAZINE MALEATE TABLET;ORAL EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No Approved Prior to Jan 1, 1982 GLAXOSMITHKLINE DISCN 详细信息
COMPAZINE 010571 002 NDA PROCHLORPERAZINE MALEATE TABLET;ORAL EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No Approved Prior to Jan 1, 1982 GLAXOSMITHKLINE DISCN 详细信息
COMPAZINE 010571 003 NDA PROCHLORPERAZINE MALEATE TABLET;ORAL EQ 25MG BASE **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
COMPLERA 202123 001 NDA EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 200MG;EQ 25MG BASE;300MG Yes Yes AB 2011/08/10 GILEAD SCIENCES INC RX 详细信息
COMTAN 020796 001 NDA ENTACAPONE TABLET;ORAL 200MG Yes Yes AB 1999/10/19 ORION PHARMA RX 详细信息
CONJUGATED ESTROGENS 214025 001 ANDA ESTROGENS, CONJUGATED TABLET;ORAL 0.3MG No No AB 2025/10/15 NOVAST LABS RX 详细信息
CONJUGATED ESTROGENS 214025 002 ANDA ESTROGENS, CONJUGATED TABLET;ORAL 0.45MG No No AB 2025/10/15 NOVAST LABS RX 详细信息
CONJUGATED ESTROGENS 214025 003 ANDA ESTROGENS, CONJUGATED TABLET;ORAL 0.625MG No No AB 2025/10/15 NOVAST LABS RX 详细信息
CONJUGATED ESTROGENS 214023 001 ANDA ESTROGENS, CONJUGATED TABLET;ORAL 0.9MG No No AB 2025/10/15 NOVAST LABS 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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