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
*Search by Trade Name,Active Ingredient,Application Number.
高级搜索
数据记录共 48215 条，共 2411 页，当前第 98 页
可点击列名称排序
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
ROCURONIUM BROMIDE 078717 002 ANDA ROCURONIUM BROMIDE INJECTABLE;INJECTION 100MG/10ML (10MG/ML) No No 2008/11/26 TEVA PHARMS DISCN 详细信息
ROCURONIUM BROMIDE 204679 001 ANDA ROCURONIUM BROMIDE INJECTABLE;INJECTION 50MG/5ML (10MG/ML) No No AP 2017/02/28 WEST WARD PHARM CORP RX 详细信息
ROCURONIUM BROMIDE 204679 002 ANDA ROCURONIUM BROMIDE INJECTABLE;INJECTION 100MG/10ML (10MG/ML) No No AP 2017/02/28 WEST WARD PHARM CORP RX 详细信息
ROMAZICON 020073 001 NDA FLUMAZENIL INJECTABLE;INJECTION 1MG/10ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1991/12/20 HOFFMANN LA ROCHE DISCN 详细信息
ROMAZICON 020073 002 NDA FLUMAZENIL INJECTABLE;INJECTION 0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1991/12/20 HOFFMANN LA ROCHE DISCN 详细信息
RUBEX 062926 001 ANDA DOXORUBICIN HYDROCHLORIDE INJECTABLE;INJECTION 10MG/VIAL No No 1989/04/13 BRISTOL MYERS SQUIBB DISCN 详细信息
RUBEX 062926 002 ANDA DOXORUBICIN HYDROCHLORIDE INJECTABLE;INJECTION 50MG/VIAL No No 1989/04/13 BRISTOL MYERS SQUIBB DISCN 详细信息
RUBEX 062926 003 ANDA DOXORUBICIN HYDROCHLORIDE INJECTABLE;INJECTION 100MG/VIAL No No 1989/04/13 BRISTOL MYERS SQUIBB DISCN 详细信息
RUBIVITE 010791 004 NDA CYANOCOBALAMIN INJECTABLE;INJECTION 0.03MG/ML No No Approved Prior to Jan 1, 1982 BEL MAR DISCN 详细信息
RUBIVITE 010791 001 NDA CYANOCOBALAMIN INJECTABLE;INJECTION 0.05MG/ML No No Approved Prior to Jan 1, 1982 BEL MAR DISCN 详细信息
RUBIVITE 010791 002 NDA CYANOCOBALAMIN INJECTABLE;INJECTION 0.1MG/ML No No Approved Prior to Jan 1, 1982 BEL MAR DISCN 详细信息
RUBIVITE 010791 005 NDA CYANOCOBALAMIN INJECTABLE;INJECTION 0.12MG/ML No No Approved Prior to Jan 1, 1982 BEL MAR DISCN 详细信息
RUBIVITE 010791 003 NDA CYANOCOBALAMIN INJECTABLE;INJECTION 1MG/ML No No Approved Prior to Jan 1, 1982 BEL MAR DISCN 详细信息
RUBRAMIN PC 006799 002 NDA CYANOCOBALAMIN INJECTABLE;INJECTION 0.1MG/ML No No Approved Prior to Jan 1, 1982 BRISTOL MYERS SQUIBB DISCN 详细信息
RUBRAMIN PC 006799 004 NDA CYANOCOBALAMIN INJECTABLE;INJECTION 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No Approved Prior to Jan 1, 1982 BRISTOL MYERS SQUIBB DISCN 详细信息
RUBRAMIN PC 006799 010 NDA CYANOCOBALAMIN INJECTABLE;INJECTION 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1988/04/28 BRISTOL MYERS SQUIBB DISCN 详细信息
RUVITE 080570 002 ANDA CYANOCOBALAMIN INJECTABLE;INJECTION 1MG/ML No No Approved Prior to Jan 1, 1982 SAVAGE LABS DISCN 详细信息
SANDIMMUNE 050573 001 NDA CYCLOSPORINE INJECTABLE;INJECTION 50MG/ML Yes Yes AP 1983/11/14 NOVARTIS RX 详细信息
SANDOSTATIN 019667 001 NDA OCTREOTIDE ACETATE INJECTABLE;INJECTION EQ 0.05MG BASE/ML Yes Yes AP 1988/10/21 NOVARTIS RX 详细信息
SANDOSTATIN 019667 002 NDA OCTREOTIDE ACETATE INJECTABLE;INJECTION EQ 0.1MG BASE/ML Yes Yes AP 1988/10/21 NOVARTIS RX 详细信息
当前数据更新日期：2026年05月23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。
©2006-2026 DrugFuture->U.S. FDA Orange Book