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 92 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
QUELICIN 008845 006 NDA SUCCINYLCHOLINE CHLORIDE INJECTABLE;INJECTION 20MG/ML Yes Yes AP Approved Prior to Jan 1, 1982 HOSPIRA RX 详细信息
QUELICIN PRESERVATIVE FREE 008845 001 NDA SUCCINYLCHOLINE CHLORIDE INJECTABLE;INJECTION 20MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No Approved Prior to Jan 1, 1982 HOSPIRA DISCN 详细信息
QUELICIN PRESERVATIVE FREE 008845 002 NDA SUCCINYLCHOLINE CHLORIDE INJECTABLE;INJECTION 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No Approved Prior to Jan 1, 1982 HOSPIRA DISCN 详细信息
QUELICIN PRESERVATIVE FREE 008845 004 NDA SUCCINYLCHOLINE CHLORIDE INJECTABLE;INJECTION 100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No Approved Prior to Jan 1, 1982 HOSPIRA DISCN 详细信息
QUINIDINE GLUCONATE 007529 002 NDA QUINIDINE GLUCONATE INJECTABLE;INJECTION 80MG/ML Yes No 1989/02/10 LILLY DISCN 详细信息
R-GENE 10 016931 001 NDA ARGININE HYDROCHLORIDE INJECTABLE;INJECTION 10GM/100ML Yes Yes Approved Prior to Jan 1, 1982 PHARMACIA AND UPJOHN RX 详细信息
RANITIDINE HYDROCHLORIDE 074764 001 ANDA RANITIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 25MG BASE/ML No No 2004/11/19 BEDFORD DISCN 详细信息
RANITIDINE HYDROCHLORIDE 074777 001 ANDA RANITIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 25MG BASE/ML No No 2005/03/02 HIKMA DISCN 详细信息
RANITIDINE HYDROCHLORIDE 077458 001 ANDA RANITIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 25MG BASE/ML No No 2006/02/16 HIKMA DISCN 详细信息
RANITIDINE HYDROCHLORIDE 079076 001 ANDA RANITIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 25MG BASE/ML No No 2016/06/09 MYLAN LABS LTD DISCN 详细信息
RANITIDINE HYDROCHLORIDE 091534 001 ANDA RANITIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 25MG BASE/ML No No 2013/02/22 ZYDUS PHARMS USA INC DISCN 详细信息
RAPLON 020984 001 NDA RAPACURONIUM BROMIDE INJECTABLE;INJECTION 100MG/VIAL No No 1999/08/18 ORGANON USA INC DISCN 详细信息
RAPLON 020984 002 NDA RAPACURONIUM BROMIDE INJECTABLE;INJECTION 200MG/VIAL No No 1999/08/18 ORGANON USA INC DISCN 详细信息
RAVOCAINE AND NOVOCAIN W/ LEVOPHED 008592 003 NDA NOREPINEPHRINE BITARTRATE; PROCAINE HYDROCHLORIDE; PROPOXYCAINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 0.033MG BASE/ML;2%;0.4% No No Approved Prior to Jan 1, 1982 EASTMAN KODAK DISCN 详细信息
RAVOCAINE AND NOVOCAIN W/ NEO-COBEFRIN 008592 007 NDA LEVONORDEFRIN; PROCAINE HYDROCHLORIDE; PROPOXYCAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.05MG/ML;2%;0.4% No No Approved Prior to Jan 1, 1982 EASTMAN KODAK DISCN 详细信息
RBC-SCAN 020063 001 NDA TECHNETIUM TC-99M RED BLOOD CELL KIT INJECTABLE;INJECTION N/A No No 1992/06/11 CADEMA DISCN 详细信息
REDISOL 006668 010 NDA CYANOCOBALAMIN INJECTABLE;INJECTION 1MG/ML No No Approved Prior to Jan 1, 1982 MERCK DISCN 详细信息
REGITINE 008278 003 NDA PHENTOLAMINE MESYLATE INJECTABLE;INJECTION 5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No Approved Prior to Jan 1, 1982 NOVARTIS DISCN 详细信息
REGLAN 017862 001 NDA METOCLOPRAMIDE HYDROCHLORIDE 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 HIKMA DISCN 详细信息
REGLAN 017862 004 NDA METOCLOPRAMIDE HYDROCHLORIDE INJECTABLE;INJECTION EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** No No 1987/05/28 HIKMA DISCN 详细信息
当前数据更新日期：2026年06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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