美国FDA药品橙皮书数据库
(U.S. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations)
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 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SODIUM INJECTABLE;INJECTION EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1987/02/11 HOFFMANN LA ROCHE DISCN 详细信息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SODIUM INJECTABLE;INJECTION EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1987/02/11 HOFFMANN LA ROCHE DISCN 详细信息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SODIUM INJECTABLE;INJECTION EQ 40MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1987/02/11 HOFFMANN LA ROCHE DISCN 详细信息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 220124 001 ANDA ROCURONIUM BROMIDE INJECTABLE;INJECTION 50MG/5ML (10MG/ML) No No AP 2026/03/04 ASPIRO RX 详细信息
ROCURONIUM BROMIDE 220124 002 ANDA ROCURONIUM BROMIDE INJECTABLE;INJECTION 100MG/10ML (10MG/ML) No No AP 2026/03/04 ASPIRO RX 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
ROCURONIUM BROMIDE 213476 001 ANDA ROCURONIUM BROMIDE INJECTABLE;INJECTION 50MG/5ML (10MG/ML) No No AP 2026/01/06 KNACK RX 详细信息
ROCURONIUM BROMIDE 213476 002 ANDA ROCURONIUM BROMIDE INJECTABLE;INJECTION 100MG/10ML (10MG/ML) No No AP 2026/01/06 KNACK RX 详细信息
ROCURONIUM BROMIDE 219674 001 ANDA ROCURONIUM BROMIDE INJECTABLE;INJECTION 50MG/5ML (10MG/ML) No No AP 2025/05/29 MANKIND PHARMA RX 详细信息
ROCURONIUM BROMIDE 219674 002 ANDA ROCURONIUM BROMIDE INJECTABLE;INJECTION 100MG/10ML (10MG/ML) No No AP 2025/05/29 MANKIND PHARMA 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。
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