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 47386 条，共 2370 页，当前第 78 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
COLY-MYCIN M 050108 002 NDA COLISTIMETHATE SODIUM INJECTABLE;INJECTION EQ 150MG BASE/VIAL Yes Yes AP Approved Prior to Jan 1, 1982 PH HEALTH RX 详细信息
COMPAZINE 010742 002 NDA PROCHLORPERAZINE EDISYLATE INJECTABLE;INJECTION EQ 5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No Approved Prior to Jan 1, 1982 GLAXOSMITHKLINE DISCN 详细信息
CONRAY 013295 001 NDA IOTHALAMATE MEGLUMINE INJECTABLE;INJECTION 60% Yes Yes Approved Prior to Jan 1, 1982 LIEBEL-FLARSHEIM RX 详细信息
CONRAY 30 016983 001 NDA IOTHALAMATE MEGLUMINE INJECTABLE;INJECTION 30% Yes No Approved Prior to Jan 1, 1982 LIEBEL-FLARSHEIM DISCN 详细信息
CONRAY 325 017685 001 NDA IOTHALAMATE SODIUM INJECTABLE;INJECTION 54.3% No No Approved Prior to Jan 1, 1982 MALLINCKRODT DISCN 详细信息
CONRAY 400 014295 001 NDA IOTHALAMATE SODIUM INJECTABLE;INJECTION 66.8% No No Approved Prior to Jan 1, 1982 MALLINCKRODT DISCN 详细信息
CONRAY 43 013295 002 NDA IOTHALAMATE MEGLUMINE INJECTABLE;INJECTION 43% Yes No Approved Prior to Jan 1, 1982 LIEBEL-FLARSHEIM DISCN 详细信息
CORDARONE 020377 001 NDA AMIODARONE HYDROCHLORIDE INJECTABLE;INJECTION 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1995/08/03 WYETH PHARMS INC DISCN 详细信息
CORLOPAM 019922 001 NDA FENOLDOPAM MESYLATE INJECTABLE;INJECTION EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1997/09/23 HOSPIRA DISCN 详细信息
CORTEF 009864 001 NDA HYDROCORTISONE INJECTABLE;INJECTION 50MG/ML No No Approved Prior to Jan 1, 1982 PHARMACIA AND UPJOHN DISCN 详细信息
CORTEF ACETATE 009378 002 NDA HYDROCORTISONE ACETATE INJECTABLE;INJECTION 50MG/ML No No Approved Prior to Jan 1, 1982 PHARMACIA AND UPJOHN DISCN 详细信息
CORTICOTROPIN 010831 001 NDA CORTICOTROPIN INJECTABLE;INJECTION 40 UNITS/ML No No Approved Prior to Jan 1, 1982 ORGANICS LAGRANGE DISCN 详细信息
CORTICOTROPIN 010831 002 NDA CORTICOTROPIN INJECTABLE;INJECTION 80 UNITS/ML No No Approved Prior to Jan 1, 1982 ORGANICS LAGRANGE DISCN 详细信息
CORTICOTROPIN 088772 001 ANDA CORTICOTROPIN INJECTABLE;INJECTION 40 UNITS/VIAL No No 1984/11/21 WATSON LABS DISCN 详细信息
CORTISONE ACETATE 008126 002 NDA CORTISONE ACETATE INJECTABLE;INJECTION 25MG/ML No No Approved Prior to Jan 1, 1982 PHARMACIA AND UPJOHN DISCN 详细信息
CORTISONE ACETATE 083147 003 ANDA CORTISONE ACETATE INJECTABLE;INJECTION 25MG/ML No No Approved Prior to Jan 1, 1982 WATSON LABS DISCN 详细信息
CORTISONE ACETATE 085677 001 ANDA CORTISONE ACETATE INJECTABLE;INJECTION 25MG/ML No No Approved Prior to Jan 1, 1982 WATSON LABS DISCN 详细信息
CORTISONE ACETATE 083147 004 ANDA CORTISONE ACETATE INJECTABLE;INJECTION 50MG/ML No No Approved Prior to Jan 1, 1982 WATSON LABS DISCN 详细信息
CORTISONE ACETATE 085677 002 ANDA CORTISONE ACETATE INJECTABLE;INJECTION 50MG/ML No No Approved Prior to Jan 1, 1982 WATSON LABS DISCN 详细信息
CORTONE 007110 002 NDA CORTISONE ACETATE INJECTABLE;INJECTION 25MG/ML No No Approved Prior to Jan 1, 1982 MERCK DISCN 详细信息
当前数据更新日期：2025年12月07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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