药品注册申请号：022150
申请类型：NDA (新药申请)
申请人：TAKEDA PHARMS USA
申请人全名：TAKEDA PHARMACEUTICALS USA INC
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 FIRAZYR ICATIBANT ACETATE INJECTABLE;SUBCUTANEOUS EQ 30MG BASE/3ML (EQ 10MG BASE/ML) Yes Yes AP 2011/08/25 2011/08/25 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
2024/01/19 SUPPL-16（补充） Approval Manufacturing (CMC) N/A ;Orphan
2022/04/28 SUPPL-14（补充） Approval Labeling STANDARD ;Orphan
2020/04/16 SUPPL-13（补充） Approval Labeling STANDARD ;Orphan
2020/04/16 SUPPL-12（补充） Approval Labeling STANDARD ;Orphan
2016/01/25 SUPPL-8（补充） Approval Manufacturing (CMC) PRIORITY
2015/11/24 SUPPL-7（补充） Approval Labeling STANDARD ;Orphan
2015/08/10 SUPPL-6（补充） Approval Labeling STANDARD ;Orphan
2013/08/30 SUPPL-4（补充） Approval Labeling STANDARD ;Orphan
2013/01/28 SUPPL-3（补充） Approval Manufacturing (CMC) PRIORITY
2012/11/28 SUPPL-2（补充） Approval Manufacturing (CMC) PRIORITY
2011/08/25 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 5648333 2014/07/15 Y Y U-1187 PDF格式**本条是由Drugfuture回溯的历史信息**
5648333 2019/07/15 Y Y U-1187 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 2016/08/25**本条是由Drugfuture回溯的历史信息**
ODE 2018/08/25**本条是由Drugfuture回溯的历史信息**
ODE-14 2018/08/25**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:ICATIBANT ACETATE 剂型/给药途径:INJECTABLE;SUBCUTANEOUS 规格:EQ 30MG BASE/3ML (EQ 10MG BASE/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
022150 001 NDA FIRAZYR ICATIBANT ACETATE INJECTABLE;SUBCUTANEOUS EQ 30MG BASE/3ML (EQ 10MG BASE/ML) Prescription Yes Yes AP 2011/08/25 TAKEDA PHARMS USA
210118 001 ANDA ICATIBANT ACETATE ICATIBANT ACETATE INJECTABLE;SUBCUTANEOUS EQ 30MG BASE/3ML (EQ 10MG BASE/ML) Prescription No No AP 2019/07/15 TEVA PHARMS USA
211021 001 ANDA ICATIBANT ACETATE ICATIBANT ACETATE INJECTABLE;SUBCUTANEOUS EQ 30MG BASE/3ML (EQ 10MG BASE/ML) Prescription No No AP 2020/03/09 JIANGSU HANSOH PHARM
208317 001 ANDA ICATIBANT ACETATE ICATIBANT ACETATE INJECTABLE;SUBCUTANEOUS EQ 30MG BASE/3ML (EQ 10MG BASE/ML) Prescription No No AP 2020/06/18 FRESENIUS KABI USA
212446 001 ANDA ICATIBANT ACETATE ICATIBANT ACETATE INJECTABLE;SUBCUTANEOUS EQ 30MG BASE/3ML (EQ 10MG BASE/ML) Prescription No No AP 2020/07/13 CIPLA
211501 001 ANDA ICATIBANT ACETATE ICATIBANT ACETATE INJECTABLE;SUBCUTANEOUS EQ 30MG BASE/3ML (EQ 10MG BASE/ML) Prescription No No AP 2020/09/01 WILSHIRE PHARMS INC
212081 001 ANDA ICATIBANT ACETATE ICATIBANT ACETATE INJECTABLE;SUBCUTANEOUS EQ 30MG BASE/3ML (EQ 10MG BASE/ML) Prescription No No AP 2020/12/16 NANG KUANG PHARM CO
213222 001 ANDA ICATIBANT ACETATE ICATIBANT ACETATE INJECTABLE;SUBCUTANEOUS EQ 30MG BASE/3ML (EQ 10MG BASE/ML) Discontinued No No AP 2021/05/21 GLENMARK PHARMS LTD
213521 001 ANDA ICATIBANT ACETATE ICATIBANT ACETATE INJECTABLE;SUBCUTANEOUS EQ 30MG BASE/3ML (EQ 10MG BASE/ML) Prescription No No AP 2023/08/14 EUGIA PHARMA
213773 001 ANDA ICATIBANT ACETATE ICATIBANT ACETATE INJECTABLE;SUBCUTANEOUS EQ 30MG BASE/3ML (EQ 10MG BASE/ML) Prescription No No AP 2024/06/14 ALEMBIC
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
参考引用2
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