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 85 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
RINGER'S IN PLASTIC CONTAINER 018721 001 NDA CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 33MG/100ML;30MG/100ML;860MG/100ML No No 1982/11/09 B BRAUN DISCN 详细信息
RINGER'S IN PLASTIC CONTAINER 020002 001 NDA CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 33MG/100ML;30MG/100ML;860MG/100ML No No AP 1992/04/17 B BRAUN RX 详细信息
RINGER'S IN PLASTIC CONTAINER 016693 001 NDA CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 33MG/100ML;30MG/100ML;860MG/100ML No No AP Approved Prior to Jan 1, 1982 BAXTER HLTHCARE RX 详细信息
RINGER'S IN PLASTIC CONTAINER 018251 001 NDA CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 33MG/100ML;30MG/100ML;860MG/100ML No No AP Approved Prior to Jan 1, 1982 OTSUKA ICU MEDCL RX 详细信息
RITODRINE HYDROCHLORIDE 071188 001 ANDA RITODRINE HYDROCHLORIDE INJECTABLE;INJECTION 10MG/ML No No 1987/07/23 ABRAXIS PHARM DISCN 详细信息
RITODRINE HYDROCHLORIDE 071189 001 ANDA RITODRINE HYDROCHLORIDE INJECTABLE;INJECTION 15MG/ML No No 1987/07/23 ABRAXIS PHARM DISCN 详细信息
RITODRINE HYDROCHLORIDE 071618 001 ANDA RITODRINE HYDROCHLORIDE INJECTABLE;INJECTION 10MG/ML No No 1991/02/28 HOSPIRA DISCN 详细信息
RITODRINE HYDROCHLORIDE 071619 001 ANDA RITODRINE HYDROCHLORIDE INJECTABLE;INJECTION 15MG/ML No No 1991/02/28 HOSPIRA DISCN 详细信息
RITODRINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER 071438 001 ANDA RITODRINE HYDROCHLORIDE INJECTABLE;INJECTION 30MG/100ML No No 1991/01/22 HOSPIRA DISCN 详细信息
ROBENGATOPE 016224 001 NDA ROSE BENGAL SODIUM I-131 INJECTABLE;INJECTION 0.5mCi/VIAL No No Approved Prior to Jan 1, 1982 BRACCO DISCN 详细信息
ROBENGATOPE 016224 002 NDA ROSE BENGAL SODIUM I-131 INJECTABLE;INJECTION 1mCi/VIAL No No Approved Prior to Jan 1, 1982 BRACCO DISCN 详细信息
ROBENGATOPE 016224 003 NDA ROSE BENGAL SODIUM I-131 INJECTABLE;INJECTION 2mCi/VIAL No No Approved Prior to Jan 1, 1982 BRACCO DISCN 详细信息
ROBINUL 017558 001 NDA GLYCOPYRROLATE INJECTABLE;INJECTION 0.2MG/ML Yes No AP Approved Prior to Jan 1, 1982 HIKMA RX 详细信息
ROBINUL 014764 001 NDA GLYCOPYRROLATE INJECTABLE;INJECTION 0.2MG/ML No No Approved Prior to Jan 1, 1982 ROBINS AH DISCN 详细信息
ROCEPHIN 062654 002 ANDA CEFTRIAXONE SODIUM INJECTABLE;INJECTION EQ 1GM BASE/VIAL No No 1987/04/30 HOFFMANN LA ROCHE DISCN 详细信息
ROCEPHIN 063239 003 ANDA CEFTRIAXONE SODIUM INJECTABLE;INJECTION EQ 1GM BASE/VIAL No No 1993/08/13 HOFFMANN LA ROCHE DISCN 详细信息
ROCEPHIN 062654 003 ANDA CEFTRIAXONE SODIUM INJECTABLE;INJECTION EQ 2GM BASE/VIAL No No 1987/04/30 HOFFMANN LA ROCHE DISCN 详细信息
ROCEPHIN 050585 005 NDA CEFTRIAXONE SODIUM INJECTABLE;INJECTION EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1984/12/21 HOFFMANN LA ROCHE DISCN 详细信息
ROCEPHIN 063239 001 ANDA CEFTRIAXONE SODIUM INJECTABLE;INJECTION EQ 250MG BASE/VIAL No No 1993/08/13 HOFFMANN LA ROCHE DISCN 详细信息
ROCEPHIN 062654 001 ANDA CEFTRIAXONE SODIUM INJECTABLE;INJECTION EQ 500MG BASE/VIAL No No 1987/04/30 HOFFMANN LA ROCHE 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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