药品注册申请号:085475
申请类型:ANDA (仿制药申请)
申请人:BAUSCH
申请人全名:BAUSCH HEALTH US LLC
产品信息
产品号商品名活性成分剂型/给药途径规格/剂量参比药物(RLD)生物等效参考标准(RS)治疗等效代码该申请号批准日期该产品号批准日期市场状态
001 LIBRIUM CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE;ORAL 25MG Yes No AB 1977/09/21 Approved Prior to Jan 1, 1982 Prescription
批准日期,申请提交历史,通知信,药品说明书,审评文件等信息
提交状态日期提交号审批结论申请内容分类审评优先级;罕用药状态通知信、审评文件、说明书、包装标签备注
2023/01/17 SUPPL-53(补充) Approval Labeling STANDARD
2021/02/05 SUPPL-51(补充) Approval Labeling STANDARD
2016/12/16 SUPPL-50(补充) Approval Labeling STANDARD
2002/09/26 SUPPL-46(补充) Approval Labeling
2002/09/26 SUPPL-45(补充) Approval Manufacturing (CMC)
2002/09/26 SUPPL-44(补充) Approval Manufacturing (CMC)
2002/09/26 SUPPL-43(补充) Approval Manufacturing (CMC)
2002/09/26 SUPPL-42(补充) Approval Manufacturing (CMC)
1997/11/28 SUPPL-40(补充) Approval Manufacturing (CMC)
1997/10/20 SUPPL-41(补充) Approval Manufacturing (CMC)
1994/11/03 SUPPL-39(补充) Approval Labeling
1991/03/27 SUPPL-38(补充) Approval Manufacturing (CMC)
1989/02/22 SUPPL-36(补充) Approval Manufacturing (CMC)
1989/02/06 SUPPL-37(补充) Approval Labeling
1988/04/01 SUPPL-35(补充) Approval Labeling
1987/11/02 SUPPL-34(补充) Approval Manufacturing (CMC)
1984/06/07 SUPPL-32(补充) Approval Manufacturing (CMC)
1983/06/09 SUPPL-31(补充) Approval Manufacturing (CMC)
1982/07/14 SUPPL-30(补充) Approval Manufacturing (CMC)
1982/05/14 SUPPL-28(补充) Approval Manufacturing (CMC)
1982/03/30 SUPPL-27(补充) Approval Manufacturing (CMC)
1977/09/21 ORIG-1(原始申请) Approval
与本品相关的专利信息(来自FDA橙皮书Orange Book)
关联产品号专利号专利过期日是否物质专利是否产品专利专利用途代码撤销请求提交日期专利下载备注
与本品相关的市场独占权保护信息
关联产品号独占权代码失效日期备注
与本品治疗等效的药品
活性成分:CHLORDIAZEPOXIDE HYDROCHLORIDE 剂型/给药途径:CAPSULE;ORAL 规格:25MG 治疗等效代码:AB
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
084679 002 ANDA CHLORDIAZEPOXIDE HYDROCHLORIDE CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE;ORAL 25MG Prescription No No AB Approved Prior to Jan 1, 1982 CHARTWELL RX
084769 001 ANDA CHLORDIAZEPOXIDE HYDROCHLORIDE CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE;ORAL 25MG Prescription No Yes AB Approved Prior to Jan 1, 1982 BARR
085475 001 ANDA LIBRIUM CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE;ORAL 25MG Prescription Yes No AB Approved Prior to Jan 1, 1982 BAUSCH
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