药品注册申请号:022311
申请类型:NDA (新药申请)
申请人:GENZYME
申请人全名:GENZYME CORP
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 MOZOBIL PLERIXAFOR SOLUTION;SUBCUTANEOUS 24MG/1.2ML (20MG/ML) Yes Yes AP 2008/12/15 2008/12/15 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
2023/09/21 SUPPL-23(补充) Approval Labeling STANDARD ;Orphan
2020/08/19 SUPPL-22(补充) Approval Labeling STANDARD ;Orphan
2019/05/30 SUPPL-20(补充) Approval Labeling STANDARD ;Orphan
2017/12/01 SUPPL-18(补充) Approval Labeling STANDARD
2016/05/12 SUPPL-17(补充) Approval Manufacturing (CMC) PRIORITY
2015/08/04 SUPPL-16(补充) Approval Labeling STANDARD ;Orphan
2014/12/04 SUPPL-15(补充) Approval Labeling STANDARD
2013/11/12 SUPPL-14(补充) Approval Manufacturing (CMC) PRIORITY
2013/06/04 SUPPL-13(补充) Approval Labeling STANDARD
2013/02/26 SUPPL-12(补充) Approval Manufacturing (CMC) PRIORITY
2010/06/14 SUPPL-1(补充) Approval Labeling UNKNOWN ;Orphan
2008/12/15 ORIG-1(原始申请) Approval Type 1 - New Molecular Entity PRIORITY ;Orphan
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 5583131 2013/12/10 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6987102 2023/07/22 U-936 PDF格式**本条是由Drugfuture回溯的历史信息**
7897590 2023/07/22 U-936 PDF格式**本条是由Drugfuture回溯的历史信息**
RE42152 2018/12/10 Y 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 NCE 2013/12/15**本条是由Drugfuture回溯的历史信息**
ODE 2015/12/15**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:PLERIXAFOR 剂型/给药途径:SOLUTION;SUBCUTANEOUS 规格:24MG/1.2ML (20MG/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
022311 001 NDA MOZOBIL PLERIXAFOR SOLUTION;SUBCUTANEOUS 24MG/1.2ML (20MG/ML) Prescription Yes Yes AP 2008/12/15 GENZYME
205182 001 ANDA PLERIXAFOR PLERIXAFOR SOLUTION;SUBCUTANEOUS 24MG/1.2ML (20MG/ML) Prescription No No AP 2023/07/24 DR REDDYS
205197 001 ANDA PLERIXAFOR PLERIXAFOR SOLUTION;SUBCUTANEOUS 24MG/1.2ML (20MG/ML) Prescription No No AP 2023/07/24 TEVA PHARMS USA INC
211901 001 ANDA PLERIXAFOR PLERIXAFOR SOLUTION;SUBCUTANEOUS 24MG/1.2ML (20MG/ML) Prescription No No AP 2023/07/24 MSN
213672 001 ANDA PLERIXAFOR PLERIXAFOR SOLUTION;SUBCUTANEOUS 24MG/1.2ML (20MG/ML) Prescription No No AP 2023/07/24 EUGIA PHARMA
215334 001 ANDA PLERIXAFOR PLERIXAFOR SOLUTION;SUBCUTANEOUS 24MG/1.2ML (20MG/ML) Prescription No No AP 2023/07/24 AMNEAL
215698 001 ANDA PLERIXAFOR PLERIXAFOR SOLUTION;SUBCUTANEOUS 24MG/1.2ML (20MG/ML) Prescription No No AP 2023/07/24 MEITHEAL
208980 001 ANDA PLERIXAFOR PLERIXAFOR SOLUTION;SUBCUTANEOUS 24MG/1.2ML (20MG/ML) Discontinued No No AP 2023/07/26 ZYDUS PHARMS
206644 001 ANDA PLERIXAFOR PLERIXAFOR SOLUTION;SUBCUTANEOUS 24MG/1.2ML (20MG/ML) Prescription No No AP 2024/05/03 GLAND PHARMA LTD
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