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 86 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
ROCEPHIN 063239 002 ANDA CEFTRIAXONE SODIUM INJECTABLE;INJECTION EQ 500MG BASE/VIAL No No 1993/08/13 HOFFMANN LA ROCHE DISCN 详细信息
ROCEPHIN 062510 003 ANDA CEFTRIAXONE SODIUM INJECTABLE;INJECTION EQ 1GM BASE/VIAL No No 1985/03/12 ROCHE DISCN 详细信息
ROCEPHIN 062510 001 ANDA CEFTRIAXONE SODIUM INJECTABLE;INJECTION EQ 250MG BASE/VIAL No No 1985/03/12 ROCHE DISCN 详细信息
ROCEPHIN 062510 002 ANDA CEFTRIAXONE SODIUM INJECTABLE;INJECTION EQ 500MG BASE/VIAL No No 1985/03/12 ROCHE DISCN 详细信息
ROCEPHIN KIT 050585 006 NDA CEFTRIAXONE SODIUM; LIDOCAINE INJECTABLE;INJECTION EQ 1GM BASE/VIAL,N/A;N/A,1% No No 1996/05/08 HOFFMANN LA ROCHE DISCN 详细信息
ROCEPHIN KIT 050585 007 NDA CEFTRIAXONE SODIUM; LIDOCAINE INJECTABLE;INJECTION EQ 500MG BASE/VIAL,N/A;N/A,1% No No 1996/05/08 HOFFMANN LA ROCHE DISCN 详细信息
ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER 050624 001 NDA CEFTRIAXONE SODIUM INJECTABLE;INJECTION EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1987/02/11 HOFFMANN LA ROCHE DISCN 详细信息
ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER 050624 002 NDA CEFTRIAXONE SODIUM INJECTABLE;INJECTION EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1987/02/11 HOFFMANN LA ROCHE DISCN 详细信息
ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER 050624 003 NDA CEFTRIAXONE SODIUM INJECTABLE;INJECTION EQ 40MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1987/02/11 HOFFMANN LA ROCHE DISCN 详细信息
ROCURONIUM BROMIDE 216234 001 ANDA ROCURONIUM BROMIDE INJECTABLE;INJECTION 50MG/5ML (10MG/ML) No No AP 2023/03/02 CAPLIN RX 详细信息
ROCURONIUM BROMIDE 216234 002 ANDA ROCURONIUM BROMIDE INJECTABLE;INJECTION 100MG/10ML (10MG/ML) No No AP 2023/03/02 CAPLIN RX 详细信息
ROCURONIUM BROMIDE 206206 001 ANDA ROCURONIUM BROMIDE INJECTABLE;INJECTION 50MG/5ML (10MG/ML) No No AP 2017/04/12 EUGIA PHARMA RX 详细信息
ROCURONIUM BROMIDE 206206 002 ANDA ROCURONIUM BROMIDE INJECTABLE;INJECTION 100MG/10ML (10MG/ML) No No AP 2017/04/12 EUGIA PHARMA RX 详细信息
ROCURONIUM BROMIDE 078651 001 ANDA ROCURONIUM BROMIDE INJECTABLE;INJECTION 50MG/5ML (10MG/ML) No No AP 2008/12/29 FRESENIUS KABI USA RX 详细信息
ROCURONIUM BROMIDE 078651 002 ANDA ROCURONIUM BROMIDE INJECTABLE;INJECTION 100MG/10ML (10MG/ML) No No AP 2008/12/29 FRESENIUS KABI USA RX 详细信息
ROCURONIUM BROMIDE 205656 001 ANDA ROCURONIUM BROMIDE INJECTABLE;INJECTION 50MG/5ML (10MG/ML) No Yes AP 2018/04/04 GLAND RX 详细信息
ROCURONIUM BROMIDE 205656 002 ANDA ROCURONIUM BROMIDE INJECTABLE;INJECTION 100MG/10ML (10MG/ML) No Yes AP 2018/04/04 GLAND RX 详细信息
ROCURONIUM BROMIDE 217034 001 ANDA ROCURONIUM BROMIDE INJECTABLE;INJECTION 50MG/5ML (10MG/ML) No No 2023/05/24 HIKMA DISCN 详细信息
ROCURONIUM BROMIDE 078519 001 ANDA ROCURONIUM BROMIDE INJECTABLE;INJECTION 50MG/5ML (10MG/ML) No No AP 2008/11/26 HOSPIRA RX 详细信息
ROCURONIUM BROMIDE 078519 002 ANDA ROCURONIUM BROMIDE INJECTABLE;INJECTION 100MG/10ML (10MG/ML) No No AP 2008/11/26 HOSPIRA RX 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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