药品注册申请号:021790
申请类型:NDA (新药申请)
申请人:OTSUKA
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 DACOGEN DECITABINE INJECTABLE;INTRAVENOUS 50MG/VIAL Yes No AP 2006/05/02 2006/05/02 Discontinued
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
2020/06/29 SUPPL-25(补充) Approval Labeling STANDARD ;Orphan
2020/02/25 SUPPL-23(补充) Approval Labeling STANDARD
2018/12/21 SUPPL-21(补充) Approval Labeling STANDARD ;Orphan
2018/12/11 SUPPL-20(补充) Approval Labeling STANDARD ;Orphan
2016/03/08 SUPPL-19(补充) Approval Manufacturing (CMC) STANDARD
2015/04/07 SUPPL-18(补充) Approval Manufacturing (CMC) STANDARD
2014/01/15 SUPPL-17(补充) Approval Manufacturing (CMC) STANDARD
2013/05/06 SUPPL-16(补充) Approval Manufacturing (CMC) STANDARD
2010/03/11 SUPPL-6(补充) Approval Efficacy STANDARD
2006/05/02 ORIG-1(原始申请) Approval Type 1 - New Molecular Entity STANDARD ;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
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 2011/05/02**本条是由Drugfuture回溯的历史信息**
ODE 2013/05/02**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:DECITABINE 剂型/给药途径:INJECTABLE;INTRAVENOUS 规格:50MG/VIAL 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
021790 001 NDA DACOGEN DECITABINE INJECTABLE;INTRAVENOUS 50MG/VIAL Discontinued Yes No AP 2006/05/02 OTSUKA
203131 001 ANDA DECITABINE DECITABINE INJECTABLE;INTRAVENOUS 50MG/VIAL Prescription No No AP 2013/07/11 DR REDDYS
202969 001 ANDA DECITABINE DECITABINE INJECTABLE;INTRAVENOUS 50MG/VIAL Prescription No No AP 2014/08/28 SANDOZ
203475 001 ANDA DECITABINE DECITABINE INJECTABLE;INTRAVENOUS 50MG/VIAL Prescription No Yes AP 2017/02/27 ACCORD HLTHCARE
204607 001 ANDA DECITABINE DECITABINE INJECTABLE;INTRAVENOUS 50MG/VIAL Prescription No No AP 2017/05/31 PHARMASCIENCE INC
206033 001 ANDA DECITABINE DECITABINE INJECTABLE;INTRAVENOUS 50MG/VIAL Prescription No No AP 2017/09/22 CHEMI SPA
207100 001 ANDA DECITABINE DECITABINE INJECTABLE;INTRAVENOUS 50MG/VIAL Prescription No No AP 2018/03/16 SAGENT PHARMS INC
210756 001 ANDA DECITABINE DECITABINE INJECTABLE;INTRAVENOUS 50MG/VIAL Prescription No No AP 2018/11/09 LUPIN LTD
209056 001 ANDA DECITABINE DECITABINE INJECTABLE;INTRAVENOUS 50MG/VIAL Prescription No No AP 2019/04/09 WOCKHARDT BIO AG
212265 001 ANDA DECITABINE DECITABINE INJECTABLE;INTRAVENOUS 50MG/VIAL Prescription No No AP 2019/08/28 MSN
210984 001 ANDA DECITABINE DECITABINE INJECTABLE;INTRAVENOUS 50MG/VIAL Prescription No No AP 2019/09/16 NOVAST LABS
205539 001 ANDA DECITABINE DECITABINE INJECTABLE;INTRAVENOUS 50MG/VIAL Prescription No No AP 2020/11/23 GLAND
212117 001 ANDA DECITABINE DECITABINE INJECTABLE;INTRAVENOUS 50MG/VIAL Prescription No No AP 2020/12/07 NIVAGEN PHARMS INC
212826 001 ANDA DECITABINE DECITABINE INJECTABLE;INTRAVENOUS 50MG/VIAL Prescription No No AP 2021/04/12 QILU PHARM HAINAN
212959 001 ANDA DECITABINE DECITABINE INJECTABLE;INTRAVENOUS 50MG/VIAL Prescription No No AP 2021/07/02 MEITHEAL
214569 001 ANDA DECITABINE DECITABINE INJECTABLE;INTRAVENOUS 50MG/VIAL Prescription No No AP 2021/09/20 EUGIA PHARMA
214486 001 ANDA DECITABINE DECITABINE INJECTABLE;INTRAVENOUS 50MG/VIAL Prescription No No AP 2021/11/19 ZYDUS PHARMS
213472 001 ANDA DECITABINE DECITABINE INJECTABLE;INTRAVENOUS 50MG/VIAL Prescription No No AP 2022/04/15 JIANGSU HANSOH PHARM
更多信息
药品NDC数据与药品包装、标签说明书
©2006-2024 DrugFuture->U.S. FDA Drugs Database