药品注册申请号：021027
申请类型：NDA (新药申请)
申请人：SANOFI
申请人全名：SANOFI GENZYME
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 HECTOROL DOXERCALCIFEROL INJECTABLE;INJECTION 4MCG/2ML (2MCG/ML) Yes Yes AP 2000/04/06 2000/04/06 Prescription
002 HECTOROL DOXERCALCIFEROL INJECTABLE;INJECTION 2MCG/ML (2MCG/ML) Yes No AP 2000/04/06 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
2022/09/28 SUPPL-38（补充） Approval Labeling STANDARD
2018/11/21 SUPPL-34（补充） Approval Labeling STANDARD
2016/06/01 SUPPL-26（补充） Approval Labeling STANDARD
2015/12/15 SUPPL-31（补充） Approval Manufacturing (CMC) STANDARD
2014/09/11 SUPPL-30（补充） Approval Manufacturing (CMC) STANDARD
2014/07/31 SUPPL-29（补充） Approval Manufacturing (CMC) STANDARD
2013/12/24 SUPPL-28（补充） Approval Manufacturing (CMC) STANDARD
2013/09/23 SUPPL-27（补充） Approval Manufacturing (CMC) STANDARD
2010/12/15 SUPPL-21（补充） Approval Manufacturing (CMC) N/A
2008/12/05 SUPPL-15（补充） Approval Manufacturing (CMC) STANDARD
2006/07/20 SUPPL-13（补充） Approval Labeling STANDARD
2005/06/22 SUPPL-12（补充） Approval Labeling STANDARD
2003/11/26 SUPPL-7（补充） Approval Manufacturing (CMC) STANDARD
2002/11/19 SUPPL-6（补充） Approval Manufacturing (CMC) STANDARD
2002/07/24 SUPPL-5（补充） Approval Manufacturing (CMC) STANDARD
2002/06/03 SUPPL-4（补充） Approval Manufacturing (CMC) STANDARD
2001/06/26 SUPPL-1（补充） Approval Manufacturing (CMC) STANDARD
2000/04/06 ORIG-1（原始申请） Approval Type 3 - New Dosage Form STANDARD
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 5602116 2014/02/11 U-321 PDF格式**本条是由Drugfuture回溯的历史信息**
5707980 2010/08/17 U-321 PDF格式**本条是由Drugfuture回溯的历史信息**
6903083 2021/07/18 Y Y PDF格式**本条是由Drugfuture回溯的历史信息**
7148211 2023/09/14 Y PDF格式**本条是由Drugfuture回溯的历史信息**
002 5602116 2014/02/11 U-321 PDF格式**本条是由Drugfuture回溯的历史信息**
7148211 2023/09/14 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
无
与本品治疗等效的药品
活性成分:DOXERCALCIFEROL 剂型/给药途径:INJECTABLE;INJECTION 规格:4MCG/2ML (2MCG/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
021027 001 NDA HECTOROL DOXERCALCIFEROL INJECTABLE;INJECTION 4MCG/2ML (2MCG/ML) Prescription Yes Yes AP 2000/04/06 SANOFI
091101 001 ANDA DOXERCALCIFEROL DOXERCALCIFEROL INJECTABLE;INJECTION 4MCG/2ML (2MCG/ML) Prescription No No AP 2013/08/30 HIKMA
200926 001 ANDA DOXERCALCIFEROL DOXERCALCIFEROL INJECTABLE;INJECTION 4MCG/2ML (2MCG/ML) Prescription No No AP 2014/02/04 SANDOZ
091333 001 ANDA DOXERCALCIFEROL DOXERCALCIFEROL INJECTABLE;INJECTION 4MCG/2ML (2MCG/ML) Prescription No No AP 2014/05/05 SANDOZ
203929 001 ANDA DOXERCALCIFEROL DOXERCALCIFEROL INJECTABLE;INJECTION 4MCG/2ML (2MCG/ML) Discontinued No No AP 2015/05/07 EPIC PHARMA LLC
208974 002 ANDA DOXERCALCIFEROL DOXERCALCIFEROL INJECTABLE;INJECTION 4MCG/2ML (2MCG/ML) Discontinued No No AP 2017/05/24 AMNEAL
208975 001 ANDA DOXERCALCIFEROL DOXERCALCIFEROL INJECTABLE;INJECTION 4MCG/2ML (2MCG/ML) Prescription No No AP 2017/05/24 AMNEAL
208614 001 NDA DOXERCALCIFEROL DOXERCALCIFEROL INJECTABLE;INJECTION 4MCG/2ML (2MCG/ML) Prescription Yes No AP 2018/07/24 HOSPIRA
210801 001 ANDA DOXERCALCIFEROL DOXERCALCIFEROL INJECTABLE;INJECTION 4MCG/2ML (2MCG/ML) Prescription No No AP 2018/11/01 LUPIN LTD
210452 001 ANDA DOXERCALCIFEROL DOXERCALCIFEROL INJECTABLE;INJECTION 4MCG/2ML (2MCG/ML) Prescription No No AP 2019/09/26 GLAND PHARMA LTD
211670 001 ANDA DOXERCALCIFEROL DOXERCALCIFEROL INJECTABLE;INJECTION 4MCG/2ML (2MCG/ML) Prescription No No AP 2020/02/07 MEITHEAL
213717 002 ANDA DOXERCALCIFEROL DOXERCALCIFEROL INJECTABLE;INJECTION 4MCG/2ML (2MCG/ML) Prescription No No AP 2022/01/24 EUGIA PHARMA
215810 001 ANDA DOXERCALCIFEROL DOXERCALCIFEROL INJECTABLE;INJECTION 4MCG/2ML (2MCG/ML) Prescription No No AP 2023/06/15 ALEMBIC
活性成分:DOXERCALCIFEROL 剂型/给药途径:INJECTABLE;INJECTION 规格:2MCG/ML (2MCG/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
021027 002 NDA HECTOROL DOXERCALCIFEROL INJECTABLE;INJECTION 2MCG/ML (2MCG/ML) Prescription Yes No AP 2000/04/06 SANOFI
203929 002 ANDA DOXERCALCIFEROL DOXERCALCIFEROL INJECTABLE;INJECTION 2MCG/ML (2MCG/ML) Discontinued No No AP 2016/03/28 EPIC PHARMA LLC
208974 001 ANDA DOXERCALCIFEROL DOXERCALCIFEROL INJECTABLE;INJECTION 2MCG/ML (2MCG/ML) Discontinued No No AP 2017/05/24 AMNEAL
213717 001 ANDA DOXERCALCIFEROL DOXERCALCIFEROL INJECTABLE;INJECTION 2MCG/ML (2MCG/ML) Prescription No No AP 2022/01/24 EUGIA PHARMA
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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