药品注册申请号:020819
申请类型:NDA (新药申请)
申请人:ABBVIE
申请人全名:ABBVIE 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 ZEMPLAR PARICALCITOL SOLUTION;INTRAVENOUS 0.005MG/ML (0.005MG/ML) Yes Yes AP 1998/04/17 1998/04/17 Prescription
002 ZEMPLAR PARICALCITOL SOLUTION;INTRAVENOUS 0.002MG/ML (0.002MG/ML) Yes Yes AP 2000/02/01 Prescription
003 ZEMPLAR PARICALCITOL SOLUTION;INTRAVENOUS 0.01MG/2ML (0.005MG/ML) Yes Yes AP 2000/02/01 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
2022/10/20 SUPPL-38(补充) Approval Labeling STANDARD ;Orphan
2021/05/12 SUPPL-37(补充) Approval Manufacturing (CMC) N/A
2021/03/02 SUPPL-36(补充) Approval Labeling STANDARD ;Orphan
2018/11/21 SUPPL-30(补充) Approval Labeling STANDARD
2016/11/30 SUPPL-32(补充) Approval Manufacturing (CMC) STANDARD
2013/07/22 SUPPL-31(补充) Approval Manufacturing (CMC) STANDARD
2011/04/06 SUPPL-25(补充) Approval Labeling UNKNOWN
2011/02/01 SUPPL-24(补充) Approval Labeling UNKNOWN
2009/08/20 SUPPL-21(补充) Approval Labeling STANDARD
2005/09/02 SUPPL-15(补充) Approval Labeling STANDARD
2004/03/31 SUPPL-14(补充) Approval Efficacy PRIORITY
2003/02/24 SUPPL-11(补充) Approval Labeling STANDARD
2003/02/24 SUPPL-7(补充) Approval Labeling STANDARD
2002/12/06 SUPPL-12(补充) Approval Manufacturing (CMC) STANDARD
2002/01/25 SUPPL-10(补充) Approval Manufacturing (CMC) STANDARD
2002/01/08 SUPPL-9(补充) Approval Manufacturing (CMC) STANDARD
2000/09/13 SUPPL-4(补充) Approval Labeling STANDARD
2000/02/02 SUPPL-3(补充) Approval Efficacy UNKNOWN
2000/02/01 SUPPL-6(补充) Approval Manufacturing (CMC) STANDARD
1999/10/18 SUPPL-5(补充) Approval Manufacturing (CMC) STANDARD
1998/04/17 ORIG-1(原始申请) Approval Type 1 - New Molecular Entity 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 5246925 2012/04/17 U-314 PDF格式**本条是由Drugfuture回溯的历史信息**
5246925*PED 2012/10/17 PDF格式**本条是由Drugfuture回溯的历史信息**
5587497 2013/12/24 PDF格式**本条是由Drugfuture回溯的历史信息**
5587497*PED 2014/06/24 PDF格式**本条是由Drugfuture回溯的历史信息**
5597815 2015/07/13 U-1195 PDF格式**本条是由Drugfuture回溯的历史信息**
5597815*PED 2016/01/13 PDF格式**本条是由Drugfuture回溯的历史信息**
6136799 2018/04/08 PDF格式**本条是由Drugfuture回溯的历史信息**
6136799*PED 2018/10/08 PDF格式**本条是由Drugfuture回溯的历史信息**
6136799*PED 2019/10/08 PDF格式**本条是由Drugfuture回溯的历史信息**
6361758 2018/04/08 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6361758*PED 2018/10/08 PDF格式**本条是由Drugfuture回溯的历史信息**
002 5246925 2012/04/17 U-314 PDF格式**本条是由Drugfuture回溯的历史信息**
5246925*PED 2012/10/17 PDF格式**本条是由Drugfuture回溯的历史信息**
5587497 2013/12/24 PDF格式**本条是由Drugfuture回溯的历史信息**
5587497*PED 2014/06/24 PDF格式**本条是由Drugfuture回溯的历史信息**
5597815 2015/07/13 U-1195 PDF格式**本条是由Drugfuture回溯的历史信息**
5597815*PED 2016/01/13 PDF格式**本条是由Drugfuture回溯的历史信息**
6136799 2018/04/08 PDF格式**本条是由Drugfuture回溯的历史信息**
6136799*PED 2018/10/08 PDF格式**本条是由Drugfuture回溯的历史信息**
6136799*PED 2019/10/08 PDF格式**本条是由Drugfuture回溯的历史信息**
6361758 2018/04/08 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6361758*PED 2018/10/08 PDF格式**本条是由Drugfuture回溯的历史信息**
003 6136799 2018/04/08 PDF格式**本条是由Drugfuture回溯的历史信息**
6136799*PED 2018/10/08 PDF格式**本条是由Drugfuture回溯的历史信息**
6361758 2018/04/08 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6361758*PED 2018/10/08 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 M-31 2007/03/31**本条是由Drugfuture回溯的历史信息**
ODE* 2023/10/18**本条是由Drugfuture回溯的历史信息**
PED 2007/10/01**本条是由Drugfuture回溯的历史信息**
002 M-31 2007/03/31**本条是由Drugfuture回溯的历史信息**
ODE* 2023/10/18**本条是由Drugfuture回溯的历史信息**
PED 2007/10/01**本条是由Drugfuture回溯的历史信息**
003 ODE* 2023/10/18**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:PARICALCITOL 剂型/给药途径:SOLUTION;INTRAVENOUS 规格:0.005MG/ML (0.005MG/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
020819 001 NDA ZEMPLAR PARICALCITOL SOLUTION;INTRAVENOUS 0.005MG/ML (0.005MG/ML) Prescription Yes Yes AP 1998/04/17 ABBVIE
091108 002 ANDA PARICALCITOL PARICALCITOL SOLUTION;INTRAVENOUS 0.005MG/ML (0.005MG/ML) Prescription No No AP 2011/07/27 SANDOZ
201657 002 NDA PARICALCITOL PARICALCITOL SOLUTION;INTRAVENOUS 0.005MG/ML (0.005MG/ML) Discontinued No No AP 2014/10/21 HOSPIRA
205917 002 NDA PARICALCITOL PARICALCITOL SOLUTION;INTRAVENOUS 0.005MG/ML (0.005MG/ML) Prescription No No AP 2014/11/18 HIKMA PHARMS
207174 002 NDA PARICALCITOL PARICALCITOL SOLUTION;INTRAVENOUS 0.005MG/ML (0.005MG/ML) Prescription No No AP 2016/02/04 ACCORD HLTHCARE
204910 002 ANDA PARICALCITOL PARICALCITOL SOLUTION;INTRAVENOUS 0.005MG/ML (0.005MG/ML) Prescription No No AP 2016/08/17 DR REDDYS
206699 002 ANDA PARICALCITOL PARICALCITOL SOLUTION;INTRAVENOUS 0.005MG/ML (0.005MG/ML) Prescription No No AP 2017/03/09 AMNEAL PHARMS CO
203897 002 ANDA PARICALCITOL PARICALCITOL SOLUTION;INTRAVENOUS 0.005MG/ML (0.005MG/ML) Prescription No No AP 2017/11/02 RISING
205982 002 ANDA PARICALCITOL PARICALCITOL SOLUTION;INTRAVENOUS 0.005MG/ML (0.005MG/ML) Prescription No No AP 2018/10/09 EUGIA PHARMA
活性成分:PARICALCITOL 剂型/给药途径:SOLUTION;INTRAVENOUS 规格:0.002MG/ML (0.002MG/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
020819 002 NDA ZEMPLAR PARICALCITOL SOLUTION;INTRAVENOUS 0.002MG/ML (0.002MG/ML) Prescription Yes Yes AP 2000/02/01 ABBVIE
091108 001 ANDA PARICALCITOL PARICALCITOL SOLUTION;INTRAVENOUS 0.002MG/ML (0.002MG/ML) Prescription No No AP 2011/07/27 SANDOZ
201657 001 NDA PARICALCITOL PARICALCITOL SOLUTION;INTRAVENOUS 0.002MG/ML (0.002MG/ML) Discontinued No No AP 2014/10/21 HOSPIRA
205917 001 NDA PARICALCITOL PARICALCITOL SOLUTION;INTRAVENOUS 0.002MG/ML (0.002MG/ML) Prescription No No AP 2014/11/18 HIKMA PHARMS
207174 001 NDA PARICALCITOL PARICALCITOL SOLUTION;INTRAVENOUS 0.002MG/ML (0.002MG/ML) Prescription No No AP 2016/02/04 ACCORD HLTHCARE
204910 001 ANDA PARICALCITOL PARICALCITOL SOLUTION;INTRAVENOUS 0.002MG/ML (0.002MG/ML) Prescription No No AP 2016/08/17 DR REDDYS
206699 001 ANDA PARICALCITOL PARICALCITOL SOLUTION;INTRAVENOUS 0.002MG/ML (0.002MG/ML) Prescription No No AP 2017/03/09 AMNEAL PHARMS CO
205982 001 ANDA PARICALCITOL PARICALCITOL SOLUTION;INTRAVENOUS 0.002MG/ML (0.002MG/ML) Prescription No No AP 2018/10/09 EUGIA PHARMA
活性成分:PARICALCITOL 剂型/给药途径:SOLUTION;INTRAVENOUS 规格:0.01MG/2ML (0.005MG/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
020819 003 NDA ZEMPLAR PARICALCITOL SOLUTION;INTRAVENOUS 0.01MG/2ML (0.005MG/ML) Prescription Yes Yes AP 2000/02/01 ABBVIE
091108 003 ANDA PARICALCITOL PARICALCITOL SOLUTION;INTRAVENOUS 0.01MG/2ML (0.005MG/ML) Prescription No No AP 2011/07/27 SANDOZ
201657 003 NDA PARICALCITOL PARICALCITOL SOLUTION;INTRAVENOUS 0.01MG/2ML (0.005MG/ML) Discontinued No No AP 2014/10/21 HOSPIRA
205917 003 NDA PARICALCITOL PARICALCITOL SOLUTION;INTRAVENOUS 0.01MG/2ML (0.005MG/ML) Prescription No No AP 2014/11/18 HIKMA PHARMS
207174 003 NDA PARICALCITOL PARICALCITOL SOLUTION;INTRAVENOUS 0.01MG/2ML (0.005MG/ML) Prescription No No AP 2016/02/04 ACCORD HLTHCARE
204910 003 ANDA PARICALCITOL PARICALCITOL SOLUTION;INTRAVENOUS 0.01MG/2ML (0.005MG/ML) Prescription No No AP 2016/08/17 DR REDDYS
206699 003 ANDA PARICALCITOL PARICALCITOL SOLUTION;INTRAVENOUS 0.01MG/2ML (0.005MG/ML) Prescription No No AP 2017/03/09 AMNEAL PHARMS CO
207692 001 ANDA PARICALCITOL PARICALCITOL SOLUTION;INTRAVENOUS 0.01MG/2ML (0.005MG/ML) Discontinued No No AP 2017/10/16 EPIC PHARMA LLC
203897 003 ANDA PARICALCITOL PARICALCITOL SOLUTION;INTRAVENOUS 0.01MG/2ML (0.005MG/ML) Prescription No No AP 2017/11/02 RISING
205982 003 ANDA PARICALCITOL PARICALCITOL SOLUTION;INTRAVENOUS 0.01MG/2ML (0.005MG/ML) Prescription No No AP 2018/10/09 EUGIA PHARMA
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