药品注册申请号:204327
申请类型:ANDA (仿制药申请)
申请人:AMNEAL PHARMS
申请人全名:AMNEAL PHARMACEUTICALS OF NEW YORK LLC
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 PARICALCITOL PARICALCITOL CAPSULE;ORAL 1MCG No No AB 2016/01/13 2016/01/13 Prescription
002 PARICALCITOL PARICALCITOL CAPSULE;ORAL 2MCG No No AB 2016/01/13 Prescription
003 PARICALCITOL PARICALCITOL CAPSULE;ORAL 4MCG No No AB 2016/01/13 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
2016/01/13 ORIG-1(原始申请) Approval
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
与本品治疗等效的药品
活性成分:PARICALCITOL 剂型/给药途径:CAPSULE;ORAL 规格:1MCG 治疗等效代码:AB
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
021606 001 NDA ZEMPLAR PARICALCITOL CAPSULE;ORAL 1MCG Prescription Yes No AB 2005/05/26 ABBVIE
090829 001 ANDA PARICALCITOL PARICALCITOL CAPSULE;ORAL 1MCG Prescription No No AB 2013/09/27 TEVA PHARMS USA
202539 001 ANDA PARICALCITOL PARICALCITOL CAPSULE;ORAL 1MCG Prescription No No AB 2014/03/27 BIONPHARMA
091412 001 ANDA PARICALCITOL PARICALCITOL CAPSULE;ORAL 1MCG Prescription No No AB 2014/06/24 DR REDDYS
202124 001 ANDA PARICALCITOL PARICALCITOL CAPSULE;ORAL 1MCG Prescription No No AB 2014/06/24 RISING
204327 001 ANDA PARICALCITOL PARICALCITOL CAPSULE;ORAL 1MCG Prescription No No AB 2016/01/13 AMNEAL PHARMS
207672 001 ANDA PARICALCITOL PARICALCITOL CAPSULE;ORAL 1MCG Prescription No No AB 2016/01/14 AUROBINDO PHARMA LTD
204948 001 ANDA PARICALCITOL PARICALCITOL CAPSULE;ORAL 1MCG Prescription No No AB 2016/10/07 MARKSANS PHARMA
活性成分:PARICALCITOL 剂型/给药途径:CAPSULE;ORAL 规格:2MCG 治疗等效代码:AB
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
021606 002 NDA ZEMPLAR PARICALCITOL CAPSULE;ORAL 2MCG Prescription Yes No AB 2005/05/26 ABBVIE
090829 002 ANDA PARICALCITOL PARICALCITOL CAPSULE;ORAL 2MCG Prescription No No AB 2013/09/27 TEVA PHARMS USA
202539 002 ANDA PARICALCITOL PARICALCITOL CAPSULE;ORAL 2MCG Prescription No No AB 2014/03/27 BIONPHARMA
091412 002 ANDA PARICALCITOL PARICALCITOL CAPSULE;ORAL 2MCG Prescription No No AB 2014/06/24 DR REDDYS
202124 002 ANDA PARICALCITOL PARICALCITOL CAPSULE;ORAL 2MCG Prescription No No AB 2014/06/24 RISING
204327 002 ANDA PARICALCITOL PARICALCITOL CAPSULE;ORAL 2MCG Prescription No No AB 2016/01/13 AMNEAL PHARMS
207672 002 ANDA PARICALCITOL PARICALCITOL CAPSULE;ORAL 2MCG Prescription No No AB 2016/01/14 AUROBINDO PHARMA LTD
204948 002 ANDA PARICALCITOL PARICALCITOL CAPSULE;ORAL 2MCG Prescription No No AB 2016/10/07 MARKSANS PHARMA
活性成分:PARICALCITOL 剂型/给药途径:CAPSULE;ORAL 规格:4MCG 治疗等效代码:AB
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
090829 003 ANDA PARICALCITOL PARICALCITOL CAPSULE;ORAL 4MCG Prescription No Yes AB 2013/09/27 TEVA PHARMS USA
202539 003 ANDA PARICALCITOL PARICALCITOL CAPSULE;ORAL 4MCG Prescription No No AB 2014/03/27 BIONPHARMA
091412 003 ANDA PARICALCITOL PARICALCITOL CAPSULE;ORAL 4MCG Prescription No No AB 2014/06/24 DR REDDYS
202124 003 ANDA PARICALCITOL PARICALCITOL CAPSULE;ORAL 4MCG Prescription No No AB 2014/06/24 RISING
204327 003 ANDA PARICALCITOL PARICALCITOL CAPSULE;ORAL 4MCG Prescription No No AB 2016/01/13 AMNEAL PHARMS
207672 003 ANDA PARICALCITOL PARICALCITOL CAPSULE;ORAL 4MCG Prescription No No AB 2016/01/14 AUROBINDO PHARMA LTD
204948 003 ANDA PARICALCITOL PARICALCITOL CAPSULE;ORAL 4MCG Prescription No No AB 2016/10/07 MARKSANS PHARMA
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药品NDC数据与药品包装、标签说明书
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