药品注册申请号:074118
申请类型:ANDA (仿制药申请)
申请人:NOSTRUM LABS INC
申请人全名:NOSTRUM LABORATORIES 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 PIROXICAM PIROXICAM CAPSULE;ORAL 20MG No No AB 1993/06/15 1993/06/15 Prescription
002 PIROXICAM PIROXICAM CAPSULE;ORAL 10MG No No AB 1993/06/15 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
2019/12/23 SUPPL-12(补充) Approval Labeling STANDARD
2019/12/23 SUPPL-10(补充) Approval Labeling STANDARD
2015/06/30 SUPPL-9(补充) Approval Labeling STANDARD
2015/06/30 SUPPL-8(补充) Approval Labeling STANDARD
2015/06/30 SUPPL-5(补充) Approval Labeling STANDARD
2011/10/21 SUPPL-3(补充) Approval Labeling
2011/09/14 SUPPL-4(补充) Approval Labeling
1993/06/15 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:PIROXICAM 剂型/给药途径:CAPSULE;ORAL 规格:20MG 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
018147 003 NDA FELDENE PIROXICAM CAPSULE;ORAL 20MG Prescription Yes Yes AB 1982/04/06 PFIZER
074131 002 ANDA PIROXICAM PIROXICAM CAPSULE;ORAL 20MG Prescription No No AB 1992/12/11 TEVA
074118 001 ANDA PIROXICAM PIROXICAM CAPSULE;ORAL 20MG Prescription No No AB 1993/06/15 NOSTRUM LABS INC
207938 002 ANDA PIROXICAM PIROXICAM CAPSULE;ORAL 20MG Discontinued No No AB 2016/09/09 FLAMINGO PHARMS
208340 002 ANDA PIROXICAM PIROXICAM CAPSULE;ORAL 20MG Prescription No No AB 2017/04/13 UNICHEM
206136 002 ANDA PIROXICAM PIROXICAM CAPSULE;ORAL 20MG Prescription No No AB 2017/06/20 STRIDES PHARMA
209256 002 ANDA PIROXICAM PIROXICAM CAPSULE;ORAL 20MG Discontinued No No AB 2017/08/11 HIKMA
206152 002 ANDA PIROXICAM PIROXICAM CAPSULE;ORAL 20MG Prescription No No AB 2017/12/29 MICRO LABS
210347 002 ANDA PIROXICAM PIROXICAM CAPSULE;ORAL 20MG Prescription No No AB 2018/01/26 STRIDES PHARMA
205585 002 ANDA PIROXICAM PIROXICAM CAPSULE;ORAL 20MG Prescription No No AB 2018/07/17 ZYDUS LIFESCIENCES
活性成分:PIROXICAM 剂型/给药途径:CAPSULE;ORAL 规格:10MG 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
018147 002 NDA FELDENE PIROXICAM CAPSULE;ORAL 10MG Prescription Yes No AB 1982/04/06 PFIZER
074131 001 ANDA PIROXICAM PIROXICAM CAPSULE;ORAL 10MG Prescription No No AB 1992/12/11 TEVA
074118 002 ANDA PIROXICAM PIROXICAM CAPSULE;ORAL 10MG Prescription No No AB 1993/06/15 NOSTRUM LABS INC
207938 001 ANDA PIROXICAM PIROXICAM CAPSULE;ORAL 10MG Discontinued No No AB 2016/09/09 FLAMINGO PHARMS
208340 001 ANDA PIROXICAM PIROXICAM CAPSULE;ORAL 10MG Prescription No No AB 2017/04/13 UNICHEM
206136 001 ANDA PIROXICAM PIROXICAM CAPSULE;ORAL 10MG Prescription No No AB 2017/06/20 STRIDES PHARMA
209256 001 ANDA PIROXICAM PIROXICAM CAPSULE;ORAL 10MG Discontinued No No AB 2017/08/11 HIKMA
206152 001 ANDA PIROXICAM PIROXICAM CAPSULE;ORAL 10MG Prescription No No AB 2017/12/29 MICRO LABS
210347 001 ANDA PIROXICAM PIROXICAM CAPSULE;ORAL 10MG Prescription No No AB 2018/01/26 STRIDES PHARMA
205585 001 ANDA PIROXICAM PIROXICAM CAPSULE;ORAL 10MG Prescription No No AB 2018/07/17 ZYDUS LIFESCIENCES
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药品NDC数据与药品包装、标签说明书
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