药品注册申请号:020954
申请类型:NDA (新药申请)
申请人:OTSUKA PHARM
申请人全名:OTSUKA PHARMACEUTICAL CO LTD
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 BUSULFEX BUSULFAN INJECTABLE;INJECTION 6MG/ML Yes Yes AP 1999/02/04 1999/02/04 Prescription
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2020/03/11 SUPPL 20 Approval Labeling STANDARD
2018/09/28 SUPPL 19 Approval Labeling STANDARD
2018/09/28 SUPPL 18 Approval Labeling STANDARD
2018/01/24 SUPPL 17 Approval Labeling STANDARD
2016/05/19 SUPPL 16 Approval Labeling STANDARD
2015/10/28 SUPPL 15 Approval Manufacturing (CMC) PRIORITY
2015/01/16 SUPPL 14 Approval Labeling STANDARD
2014/09/04 SUPPL 13 Approval Manufacturing (CMC) PRIORITY
2011/06/23 SUPPL 10 Approval Labeling UNKNOWN
2011/06/23 SUPPL 9 Approval Labeling STANDARD
2007/04/19 SUPPL 8 Approval Manufacturing (CMC) N/A
2003/01/13 SUPPL 4 Approval Efficacy PRIORITY
2002/12/23 SUPPL 1 Approval Labeling STANDARD
2002/11/13 SUPPL 5 Approval Manufacturing (CMC) PRIORITY
2002/04/24 SUPPL 3 Approval Labeling STANDARD
1999/12/07 SUPPL 2 Approval Manufacturing (CMC) PRIORITY
1999/02/04 ORIG 1 Approval Type 3 - New Dosage Form PRIORITY
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
001 5430057 2013/09/30 U-263 PDF格式**本条是由Drugfuture回溯的历史信息**
5430057*PED 2014/03/30 U-263 PDF格式**本条是由Drugfuture回溯的历史信息**
5559148 2013/09/30 U-264 PDF格式**本条是由Drugfuture回溯的历史信息**
5559148*PED 2014/03/30 U-264 PDF格式**本条是由Drugfuture回溯的历史信息**
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
001 PED 2006/08/04**本条是由Drugfuture回溯的历史信息**
与本品治疗等效的药品
活性成分:BUSULFAN 剂型/给药途径:INJECTABLE;INJECTION 规格:6MG/ML 治疗等效代码:AP
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
020954 001 NDA BUSULFEX BUSULFAN INJECTABLE;INJECTION 6MG/ML Prescription Yes Yes AP 1999/02/04 OTSUKA PHARM
202259 001 ANDA BUSULFAN BUSULFAN INJECTABLE;INJECTION 6MG/ML Prescription No No AP 2015/12/22 LUITPOLD
207050 001 ANDA BUSULFAN BUSULFAN INJECTABLE;INJECTION 6MG/ML Prescription No No AP 2017/03/24 PHARMASCIENCE INC
208536 001 ANDA BUSULFAN BUSULFAN INJECTABLE;INJECTION 6MG/ML Prescription No No AP 2017/11/20 MYLAN INSTITUTIONAL
205139 001 ANDA BUSULFAN BUSULFAN INJECTABLE;INJECTION 6MG/ML Prescription No No AP 2017/12/08 ACTAVIS LLC
209580 001 ANDA BUSULFAN BUSULFAN INJECTABLE;INJECTION 6MG/ML Prescription No No AP 2017/12/18 AMNEAL
205672 001 ANDA BUSULFAN BUSULFAN INJECTABLE;INJECTION 6MG/ML Prescription No No AP 2018/07/31 HOSPIRA INC
205106 001 ANDA BUSULFAN BUSULFAN INJECTABLE;INJECTION 6MG/ML Prescription No No AP 2018/09/21 ATHENEX INC
207794 001 ANDA BUSULFAN BUSULFAN INJECTABLE;INJECTION 6MG/ML Prescription No No AP 2019/01/14 NEXUS PHARMS
210148 001 ANDA BUSULFAN BUSULFAN INJECTABLE;INJECTION 6MG/ML Prescription No No AP 2019/02/22 ACCORD HLTHCARE INC
210931 001 ANDA BUSULFAN BUSULFAN INJECTABLE;INJECTION 6MG/ML Prescription No No AP 2019/04/18 SHILPA MEDICARE LTD
210448 001 ANDA BUSULFAN BUSULFAN INJECTABLE;INJECTION 6MG/ML Prescription No No AP 2019/05/07 APOTEX
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