药品注册申请号：203202
申请类型：NDA (新药申请)
申请人：LUNDBECK NA LTD
申请人全名：LUNDBECK NA 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 NORTHERA DROXIDOPA CAPSULE;ORAL 100MG Yes No AB 2014/02/18 2014/02/18 Prescription
002 NORTHERA DROXIDOPA CAPSULE;ORAL 200MG Yes No AB 2014/02/18 Prescription
003 NORTHERA DROXIDOPA CAPSULE;ORAL 300MG Yes Yes AB 2014/02/18 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
2017/02/10 SUPPL-7（补充） Approval Labeling STANDARD
2016/10/03 SUPPL-6（补充） Approval Labeling STANDARD ;Orphan
2015/08/24 SUPPL-5（补充） Approval Manufacturing (CMC) PRIORITY
2015/08/19 SUPPL-4（补充） Approval Manufacturing (CMC) PRIORITY
2014/11/03 SUPPL-3（补充） Approval Manufacturing (CMC) PRIORITY
2014/11/03 SUPPL-1（补充） Approval Manufacturing (CMC) PRIORITY ;Orphan
2014/09/30 SUPPL-2（补充） Approval Manufacturing (CMC) PRIORITY
2014/02/18 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
无
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 2019/02/18**本条是由Drugfuture回溯的历史信息**
ODE 2021/02/18**本条是由Drugfuture回溯的历史信息**
ODE-61 2021/02/18**本条是由Drugfuture回溯的历史信息**
002 NCE 2019/02/18**本条是由Drugfuture回溯的历史信息**
ODE 2021/02/18**本条是由Drugfuture回溯的历史信息**
ODE-61 2021/02/18**本条是由Drugfuture回溯的历史信息**
003 NCE 2019/02/18**本条是由Drugfuture回溯的历史信息**
ODE 2021/02/18**本条是由Drugfuture回溯的历史信息**
ODE-61 2021/02/18**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:DROXIDOPA 剂型/给药途径:CAPSULE;ORAL 规格:100MG 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
203202 001 NDA NORTHERA DROXIDOPA CAPSULE;ORAL 100MG Prescription Yes No AB 2014/02/18 LUNDBECK NA LTD
211652 001 ANDA DROXIDOPA DROXIDOPA CAPSULE;ORAL 100MG Prescription No No AB 2021/02/18 LUPIN PHARMS
214384 001 ANDA DROXIDOPA DROXIDOPA CAPSULE;ORAL 100MG Prescription No No AB 2021/02/18 SUN PHARM
214387 001 ANDA DROXIDOPA DROXIDOPA CAPSULE;ORAL 100MG Prescription No No AB 2021/02/18 AUROBINDO PHARMA LTD
214391 001 ANDA DROXIDOPA DROXIDOPA CAPSULE;ORAL 100MG Prescription No No AB 2021/02/18 AJANTA PHARMA LTD
211741 001 ANDA DROXIDOPA DROXIDOPA CAPSULE;ORAL 100MG Prescription No No AB 2021/02/18 MSN PHARMS INC
211818 001 ANDA DROXIDOPA DROXIDOPA CAPSULE;ORAL 100MG Prescription No No AB 2021/02/18 ZYDUS PHARMS
212835 001 ANDA DROXIDOPA DROXIDOPA CAPSULE;ORAL 100MG Discontinued No No AB 2021/02/18 HIKMA
213661 001 ANDA DROXIDOPA DROXIDOPA CAPSULE;ORAL 100MG Discontinued No No AB 2021/02/18 UPSHER SMITH LABS
213911 001 ANDA DROXIDOPA DROXIDOPA CAPSULE;ORAL 100MG Prescription No No AB 2021/02/18 ALKEM LABS LTD
214017 001 ANDA DROXIDOPA DROXIDOPA CAPSULE;ORAL 100MG Prescription No No AB 2021/02/18 SCIEGEN PHARMS INC
213033 001 ANDA DROXIDOPA DROXIDOPA CAPSULE;ORAL 100MG Prescription No No AB 2021/04/28 BIONPHARMA
214543 001 ANDA DROXIDOPA DROXIDOPA CAPSULE;ORAL 100MG Prescription No No AB 2021/05/05 SOMERSET THERAPS LLC
211726 002 ANDA DROXIDOPA DROXIDOPA CAPSULE;ORAL 100MG Prescription No No AB 2021/08/09 ANNORA
215265 001 ANDA DROXIDOPA DROXIDOPA CAPSULE;ORAL 100MG Prescription No No AB 2021/11/01 ADAPTIS
214217 001 ANDA DROXIDOPA DROXIDOPA CAPSULE;ORAL 100MG Discontinued No No AB 2022/05/05 CHARTWELL RX
活性成分:DROXIDOPA 剂型/给药途径:CAPSULE;ORAL 规格:200MG 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
203202 002 NDA NORTHERA DROXIDOPA CAPSULE;ORAL 200MG Prescription Yes No AB 2014/02/18 LUNDBECK NA LTD
211652 002 ANDA DROXIDOPA DROXIDOPA CAPSULE;ORAL 200MG Prescription No No AB 2021/02/18 LUPIN PHARMS
214384 002 ANDA DROXIDOPA DROXIDOPA CAPSULE;ORAL 200MG Prescription No No AB 2021/02/18 SUN PHARM
214387 002 ANDA DROXIDOPA DROXIDOPA CAPSULE;ORAL 200MG Prescription No No AB 2021/02/18 AUROBINDO PHARMA LTD
214391 002 ANDA DROXIDOPA DROXIDOPA CAPSULE;ORAL 200MG Prescription No No AB 2021/02/18 AJANTA PHARMA LTD
211741 002 ANDA DROXIDOPA DROXIDOPA CAPSULE;ORAL 200MG Prescription No No AB 2021/02/18 MSN PHARMS INC
211818 002 ANDA DROXIDOPA DROXIDOPA CAPSULE;ORAL 200MG Prescription No No AB 2021/02/18 ZYDUS PHARMS
212835 002 ANDA DROXIDOPA DROXIDOPA CAPSULE;ORAL 200MG Discontinued No No AB 2021/02/18 HIKMA
213661 002 ANDA DROXIDOPA DROXIDOPA CAPSULE;ORAL 200MG Discontinued No No AB 2021/02/18 UPSHER SMITH LABS
213911 002 ANDA DROXIDOPA DROXIDOPA CAPSULE;ORAL 200MG Prescription No No AB 2021/02/18 ALKEM LABS LTD
214017 002 ANDA DROXIDOPA DROXIDOPA CAPSULE;ORAL 200MG Prescription No No AB 2021/02/18 SCIEGEN PHARMS INC
213033 002 ANDA DROXIDOPA DROXIDOPA CAPSULE;ORAL 200MG Prescription No No AB 2021/04/28 BIONPHARMA
214543 002 ANDA DROXIDOPA DROXIDOPA CAPSULE;ORAL 200MG Prescription No No AB 2021/05/05 SOMERSET THERAPS LLC
211726 003 ANDA DROXIDOPA DROXIDOPA CAPSULE;ORAL 200MG Prescription No No AB 2021/08/09 ANNORA
215265 002 ANDA DROXIDOPA DROXIDOPA CAPSULE;ORAL 200MG Prescription No No AB 2021/11/01 ADAPTIS
214217 002 ANDA DROXIDOPA DROXIDOPA CAPSULE;ORAL 200MG Discontinued No No AB 2022/05/05 CHARTWELL RX
活性成分:DROXIDOPA 剂型/给药途径:CAPSULE;ORAL 规格:300MG 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
203202 003 NDA NORTHERA DROXIDOPA CAPSULE;ORAL 300MG Prescription Yes Yes AB 2014/02/18 LUNDBECK NA LTD
211652 003 ANDA DROXIDOPA DROXIDOPA CAPSULE;ORAL 300MG Prescription No No AB 2021/02/18 LUPIN PHARMS
211726 001 ANDA DROXIDOPA DROXIDOPA CAPSULE;ORAL 300MG Prescription No No AB 2021/02/18 ANNORA
211741 003 ANDA DROXIDOPA DROXIDOPA CAPSULE;ORAL 300MG Prescription No No AB 2021/02/18 MSN PHARMS INC
211818 003 ANDA DROXIDOPA DROXIDOPA CAPSULE;ORAL 300MG Prescription No No AB 2021/02/18 ZYDUS PHARMS
212835 003 ANDA DROXIDOPA DROXIDOPA CAPSULE;ORAL 300MG Discontinued No No AB 2021/02/18 HIKMA
213661 003 ANDA DROXIDOPA DROXIDOPA CAPSULE;ORAL 300MG Discontinued No No AB 2021/02/18 UPSHER SMITH LABS
213911 003 ANDA DROXIDOPA DROXIDOPA CAPSULE;ORAL 300MG Prescription No No AB 2021/02/18 ALKEM LABS LTD
214017 003 ANDA DROXIDOPA DROXIDOPA CAPSULE;ORAL 300MG Prescription No No AB 2021/02/18 SCIEGEN PHARMS INC
214384 003 ANDA DROXIDOPA DROXIDOPA CAPSULE;ORAL 300MG Prescription No No AB 2021/02/18 SUN PHARM
214387 003 ANDA DROXIDOPA DROXIDOPA CAPSULE;ORAL 300MG Prescription No No AB 2021/02/18 AUROBINDO PHARMA LTD
214391 003 ANDA DROXIDOPA DROXIDOPA CAPSULE;ORAL 300MG Prescription No No AB 2021/02/18 AJANTA PHARMA LTD
213033 003 ANDA DROXIDOPA DROXIDOPA CAPSULE;ORAL 300MG Prescription No No AB 2021/04/28 BIONPHARMA
214543 003 ANDA DROXIDOPA DROXIDOPA CAPSULE;ORAL 300MG Prescription No No AB 2021/05/05 SOMERSET THERAPS LLC
215265 003 ANDA DROXIDOPA DROXIDOPA CAPSULE;ORAL 300MG Prescription No No AB 2021/11/01 ADAPTIS
214217 003 ANDA DROXIDOPA DROXIDOPA CAPSULE;ORAL 300MG Discontinued No No AB 2022/05/05 CHARTWELL RX
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
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