药品注册申请号：200904
申请类型：ANDA (仿制药申请)
申请人：SANDOZ
申请人全名：SANDOZ 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 LINEZOLID LINEZOLID SOLUTION;INTRAVENOUS 200MG/100ML (2MG/ML) No No AP;AP 2015/07/16 2015/07/16 Prescription
002 LINEZOLID LINEZOLID SOLUTION;INTRAVENOUS 600MG/300ML (2MG/ML) No No AP;AP 2015/07/16 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
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2015/07/16 ORIG-2（原始申请） Approval Not Applicable
2015/07/16 ORIG-1（原始申请） Approval Not Applicable
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2025/07/03 SUPPL-16（补充） Approval Labeling-Package Insert STANDARD
2023/12/22 SUPPL-14（补充） Approval Labeling-Package Insert STANDARD
2023/12/22 SUPPL-13（补充） Approval Labeling-Package Insert STANDARD
2023/12/22 SUPPL-12（补充） Approval Labeling-Package Insert STANDARD
2023/12/22 SUPPL-11（补充） Approval Labeling-Package Insert STANDARD
2019/05/28 SUPPL-8（补充） Approval Labeling-Package Insert STANDARD
2019/05/28 SUPPL-4（补充） Approval Labeling-Package Insert 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
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
无
与本品治疗等效的药品
>>>活性成分:LINEZOLID; 剂型/给药途径:SOLUTION;INTRAVENOUS; 规格:200MG/100ML (2MG/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
021131 001 NDA ZYVOX LINEZOLID SOLUTION;INTRAVENOUS 200MG/100ML (2MG/ML) Prescription Yes No AP 2000/04/18 PFIZER
200904 001 ANDA LINEZOLID LINEZOLID SOLUTION;INTRAVENOUS 200MG/100ML (2MG/ML) Prescription No No AP 2015/07/16 SANDOZ
207354 001 ANDA LINEZOLID LINEZOLID SOLUTION;INTRAVENOUS 200MG/100ML (2MG/ML) Prescription No No AP 2016/12/20 NANG KUANG PHARM CO
204696 001 ANDA LINEZOLID LINEZOLID SOLUTION;INTRAVENOUS 200MG/100ML (2MG/ML) Prescription No No AP 2017/03/02 SAGENT PHARMS INC
207001 001 ANDA LINEZOLID LINEZOLID SOLUTION;INTRAVENOUS 200MG/100ML (2MG/ML) Prescription No No AP 2017/07/07 HQ SPCLT PHARMA
205154 001 ANDA LINEZOLID LINEZOLID SOLUTION;INTRAVENOUS 200MG/100ML (2MG/ML) Prescription No No AP 2017/12/06 PHARMOBEDIENT
>>>活性成分:LINEZOLID; 剂型/给药途径:SOLUTION;INTRAVENOUS; 规格:200MG/100ML (2MG/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
021131 001 NDA ZYVOX LINEZOLID SOLUTION;INTRAVENOUS 200MG/100ML (2MG/ML) Prescription Yes No AP 2000/04/18 PFIZER
200904 001 ANDA LINEZOLID LINEZOLID SOLUTION;INTRAVENOUS 200MG/100ML (2MG/ML) Prescription No No AP 2015/07/16 SANDOZ
207354 001 ANDA LINEZOLID LINEZOLID SOLUTION;INTRAVENOUS 200MG/100ML (2MG/ML) Prescription No No AP 2016/12/20 NANG KUANG PHARM CO
204696 001 ANDA LINEZOLID LINEZOLID SOLUTION;INTRAVENOUS 200MG/100ML (2MG/ML) Prescription No No AP 2017/03/02 SAGENT PHARMS INC
207001 001 ANDA LINEZOLID LINEZOLID SOLUTION;INTRAVENOUS 200MG/100ML (2MG/ML) Prescription No No AP 2017/07/07 HQ SPCLT PHARMA
205154 001 ANDA LINEZOLID LINEZOLID SOLUTION;INTRAVENOUS 200MG/100ML (2MG/ML) Prescription No No AP 2017/12/06 PHARMOBEDIENT
>>>活性成分:LINEZOLID; 剂型/给药途径:SOLUTION;INTRAVENOUS; 规格:600MG/300ML (2MG/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
021131 003 NDA ZYVOX LINEZOLID SOLUTION;INTRAVENOUS 600MG/300ML (2MG/ML) Prescription Yes Yes AP 2000/04/18 PFIZER
200222 001 ANDA LINEZOLID LINEZOLID SOLUTION;INTRAVENOUS 600MG/300ML (2MG/ML) Discontinued No No AP 2012/06/27 TEVA PHARMS
200904 002 ANDA LINEZOLID LINEZOLID SOLUTION;INTRAVENOUS 600MG/300ML (2MG/ML) Prescription No No AP 2015/07/16 SANDOZ
204764 001 ANDA LINEZOLID LINEZOLID SOLUTION;INTRAVENOUS 600MG/300ML (2MG/ML) Prescription No No AP 2016/03/15 FRESENIUS KABI USA
206917 001 ANDA LINEZOLID LINEZOLID SOLUTION;INTRAVENOUS 600MG/300ML (2MG/ML) Prescription No No AP 2016/08/04 EUGIA PHARMA
207354 002 ANDA LINEZOLID LINEZOLID SOLUTION;INTRAVENOUS 600MG/300ML (2MG/ML) Prescription No No AP 2016/12/20 NANG KUANG PHARM CO
204696 002 ANDA LINEZOLID LINEZOLID SOLUTION;INTRAVENOUS 600MG/300ML (2MG/ML) Prescription No No AP 2017/03/02 SAGENT PHARMS INC
207001 002 ANDA LINEZOLID LINEZOLID SOLUTION;INTRAVENOUS 600MG/300ML (2MG/ML) Prescription No No AP 2017/07/07 HQ SPCLT PHARMA
205154 002 ANDA LINEZOLID LINEZOLID SOLUTION;INTRAVENOUS 600MG/300ML (2MG/ML) Prescription No No AP 2017/12/06 PHARMOBEDIENT
206454 001 ANDA LINEZOLID LINEZOLID SOLUTION;INTRAVENOUS 600MG/300ML (2MG/ML) Prescription No No AP 2022/08/22 HIKMA
>>>活性成分:LINEZOLID; 剂型/给药途径:SOLUTION;INTRAVENOUS; 规格:600MG/300ML (2MG/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
021131 003 NDA ZYVOX LINEZOLID SOLUTION;INTRAVENOUS 600MG/300ML (2MG/ML) Prescription Yes Yes AP 2000/04/18 PFIZER
200222 001 ANDA LINEZOLID LINEZOLID SOLUTION;INTRAVENOUS 600MG/300ML (2MG/ML) Discontinued No No AP 2012/06/27 TEVA PHARMS
200904 002 ANDA LINEZOLID LINEZOLID SOLUTION;INTRAVENOUS 600MG/300ML (2MG/ML) Prescription No No AP 2015/07/16 SANDOZ
204764 001 ANDA LINEZOLID LINEZOLID SOLUTION;INTRAVENOUS 600MG/300ML (2MG/ML) Prescription No No AP 2016/03/15 FRESENIUS KABI USA
206917 001 ANDA LINEZOLID LINEZOLID SOLUTION;INTRAVENOUS 600MG/300ML (2MG/ML) Prescription No No AP 2016/08/04 EUGIA PHARMA
207354 002 ANDA LINEZOLID LINEZOLID SOLUTION;INTRAVENOUS 600MG/300ML (2MG/ML) Prescription No No AP 2016/12/20 NANG KUANG PHARM CO
204696 002 ANDA LINEZOLID LINEZOLID SOLUTION;INTRAVENOUS 600MG/300ML (2MG/ML) Prescription No No AP 2017/03/02 SAGENT PHARMS INC
207001 002 ANDA LINEZOLID LINEZOLID SOLUTION;INTRAVENOUS 600MG/300ML (2MG/ML) Prescription No No AP 2017/07/07 HQ SPCLT PHARMA
205154 002 ANDA LINEZOLID LINEZOLID SOLUTION;INTRAVENOUS 600MG/300ML (2MG/ML) Prescription No No AP 2017/12/06 PHARMOBEDIENT
206454 001 ANDA LINEZOLID LINEZOLID SOLUTION;INTRAVENOUS 600MG/300ML (2MG/ML) Prescription No No AP 2022/08/22 HIKMA
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
参考引用2
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