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 47486 条，共 2375 页，当前第 83 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
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MESYLATE INJECTABLE;INJECTION 5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No Approved Prior to Jan 1, 1982 NOVARTIS DISCN 详细信息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HYDROCHLORIDE INJECTABLE;INJECTION EQ 5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No Approved Prior to Jan 1, 1982 HIKMA DISCN 详细信息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INJECTABLE;INJECTION EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** No No 1987/05/28 HIKMA DISCN 详细信息
REGONOL 017398 001 NDA PYRIDOSTIGMINE BROMIDE INJECTABLE;INJECTION 5MG/ML No No AP Approved Prior to Jan 1, 1982 SANDOZ RX 详细信息
REMIFENTANIL HYDROCHLORIDE 206223 001 ANDA REMIFENTANIL HYDROCHLORIDE INJECTABLE;INJECTION EQ 1MG BASE/VIAL No No AP 2018/01/16 FRESENIUS KABI USA RX 详细信息
REMIFENTANIL HYDROCHLORIDE 206223 002 ANDA REMIFENTANIL HYDROCHLORIDE INJECTABLE;INJECTION EQ 2MG BASE/VIAL No No AP 2018/01/16 FRESENIUS KABI USA RX 详细信息
REMIFENTANIL HYDROCHLORIDE 206223 003 ANDA REMIFENTANIL HYDROCHLORIDE INJECTABLE;INJECTION EQ 5MG BASE/VIAL No No AP 2018/01/16 FRESENIUS KABI USA RX 详细信息
REMIFENTANIL HYDROCHLORIDE 210594 001 ANDA REMIFENTANIL HYDROCHLORIDE INJECTABLE;INJECTION EQ 1MG BASE/VIAL No No AP 2020/10/13 HIKMA RX 详细信息
REMIFENTANIL HYDROCHLORIDE 210594 002 ANDA REMIFENTANIL HYDROCHLORIDE INJECTABLE;INJECTION EQ 2MG BASE/VIAL No No AP 2020/10/13 HIKMA RX 详细信息
REMIFENTANIL HYDROCHLORIDE 210594 003 ANDA REMIFENTANIL HYDROCHLORIDE INJECTABLE;INJECTION EQ 5MG BASE/VIAL No No AP 2020/10/13 HIKMA RX 详细信息
REMIFENTANIL HYDROCHLORIDE 215635 001 ANDA REMIFENTANIL HYDROCHLORIDE INJECTABLE;INJECTION EQ 1MG BASE/VIAL No No AP 2024/06/28 NIVAGEN PHARMS INC RX 详细信息
REMIFENTANIL HYDROCHLORIDE 215635 002 ANDA REMIFENTANIL HYDROCHLORIDE INJECTABLE;INJECTION EQ 2MG BASE/VIAL No No AP 2024/06/28 NIVAGEN PHARMS INC RX 详细信息
REMIFENTANIL HYDROCHLORIDE 215635 003 ANDA REMIFENTANIL HYDROCHLORIDE INJECTABLE;INJECTION EQ 5MG BASE/VIAL No No AP 2024/06/28 NIVAGEN PHARMS INC RX 详细信息
RENAMIN W/O ELECTROLYTES 017493 007 NDA AMINO ACIDS INJECTABLE;INJECTION 6.5% (6.5GM/100ML) No No 1982/10/15 BAXTER HLTHCARE DISCN 详细信息
RENO-60 010040 016 NDA DIATRIZOATE MEGLUMINE INJECTABLE;INJECTION 60% No No Approved Prior to Jan 1, 1982 BRACCO DISCN 详细信息
RENO-DIP 010040 012 NDA DIATRIZOATE MEGLUMINE INJECTABLE;INJECTION 30% No No Approved Prior to Jan 1, 1982 BRACCO DISCN 详细信息
RENOCAL-76 089347 001 ANDA DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM INJECTABLE;INJECTION 66%;10% No No 1988/06/01 BRACCO DISCN 详细信息
当前数据更新日期：2025年12月16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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