药品注册申请号：207160
申请类型：ANDA (仿制药申请)
申请人：EUGIA PHARMA
申请人全名：EUGIA PHARMA SPECIALITIES 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 LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM INJECTABLE;INTRAVENOUS 500MG/100ML (5MG/ML) No No AP 2017/01/04 2017/01/04 Prescription
002 LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM INJECTABLE;INTRAVENOUS 1GM/100ML (10MG/ML) No No AP 2017/01/04 Prescription
003 LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM INJECTABLE;INTRAVENOUS 1.5GM/100ML (15MG/ML) No No AP 2017/01/04 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
2017/01/04 ORIG-1（原始申请） Approval STANDARD
>>>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
2025/03/10 SUPPL-9（补充） Approval Labeling-Package Insert STANDARD
2023/05/23 SUPPL-5（补充） Approval Labeling-Package Insert STANDARD
2020/07/11 SUPPL-4（补充） Approval Labeling-Package Insert STANDARD
2020/07/11 SUPPL-3（补充） Approval Labeling-Patient Package Insert STANDARD
2020/07/11 SUPPL-2（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:LEVETIRACETAM; 剂型/给药途径:INJECTABLE;INTRAVENOUS; 规格:500MG/100ML (5MG/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
202543 001 NDA LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM INJECTABLE;INTRAVENOUS 500MG/100ML (5MG/ML) Prescription Yes Yes AP 2011/11/09 HQ SPCLT PHARMA
207160 001 ANDA LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM INJECTABLE;INTRAVENOUS 500MG/100ML (5MG/ML) Prescription No No AP 2017/01/04 EUGIA PHARMA
206880 001 ANDA LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM INJECTABLE;INTRAVENOUS 500MG/100ML (5MG/ML) Prescription No No AP 2017/10/25 GLAND
213532 001 ANDA LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM INJECTABLE;INTRAVENOUS 500MG/100ML (5MG/ML) Prescription No No AP 2020/07/06 NEXUS
208619 001 ANDA LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM INJECTABLE;INTRAVENOUS 500MG/100ML (5MG/ML) Prescription No No AP 2023/01/31 FRESENIUS KABI USA
217059 001 ANDA LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM INJECTABLE;INTRAVENOUS 500MG/100ML (5MG/ML) Prescription No No AP 2023/10/02 BAXTER HLTHCARE CORP
211356 001 ANDA LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM INJECTABLE;INTRAVENOUS 500MG/100ML (5MG/ML) Prescription No No AP 2024/02/12 HIKMA
209705 001 ANDA LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM INJECTABLE;INTRAVENOUS 500MG/100ML (5MG/ML) Prescription No No AP 2024/02/27 B BRAUN MEDICAL
219562 001 ANDA LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM INJECTABLE;INTRAVENOUS 500MG/100ML (5MG/ML) Prescription No No AP 2025/01/16 CAPLIN
>>>活性成分:LEVETIRACETAM; 剂型/给药途径:INJECTABLE;INTRAVENOUS; 规格:1GM/100ML (10MG/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
202543 002 NDA LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM INJECTABLE;INTRAVENOUS 1GM/100ML (10MG/ML) Prescription Yes Yes AP 2011/11/09 HQ SPCLT PHARMA
207160 002 ANDA LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM INJECTABLE;INTRAVENOUS 1GM/100ML (10MG/ML) Prescription No No AP 2017/01/04 EUGIA PHARMA
206880 002 ANDA LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM INJECTABLE;INTRAVENOUS 1GM/100ML (10MG/ML) Prescription No No AP 2017/10/25 GLAND
213532 002 ANDA LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM INJECTABLE;INTRAVENOUS 1GM/100ML (10MG/ML) Prescription No No AP 2020/07/06 NEXUS
208619 002 ANDA LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM INJECTABLE;INTRAVENOUS 1GM/100ML (10MG/ML) Prescription No No AP 2023/01/31 FRESENIUS KABI USA
217059 002 ANDA LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM INJECTABLE;INTRAVENOUS 1GM/100ML (10MG/ML) Prescription No No AP 2023/10/02 BAXTER HLTHCARE CORP
211356 002 ANDA LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM INJECTABLE;INTRAVENOUS 1GM/100ML (10MG/ML) Prescription No No AP 2024/02/12 HIKMA
209705 002 ANDA LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM INJECTABLE;INTRAVENOUS 1GM/100ML (10MG/ML) Prescription No No AP 2024/02/27 B BRAUN MEDICAL
219562 002 ANDA LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM INJECTABLE;INTRAVENOUS 1GM/100ML (10MG/ML) Prescription No No AP 2025/01/16 CAPLIN
>>>活性成分:LEVETIRACETAM; 剂型/给药途径:INJECTABLE;INTRAVENOUS; 规格:1.5GM/100ML (15MG/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
202543 003 NDA LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM INJECTABLE;INTRAVENOUS 1.5GM/100ML (15MG/ML) Prescription Yes Yes AP 2011/11/09 HQ SPCLT PHARMA
207160 003 ANDA LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM INJECTABLE;INTRAVENOUS 1.5GM/100ML (15MG/ML) Prescription No No AP 2017/01/04 EUGIA PHARMA
206880 003 ANDA LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM INJECTABLE;INTRAVENOUS 1.5GM/100ML (15MG/ML) Prescription No No AP 2017/10/25 GLAND
213532 003 ANDA LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM INJECTABLE;INTRAVENOUS 1.5GM/100ML (15MG/ML) Prescription No No AP 2020/07/06 NEXUS
208619 003 ANDA LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM INJECTABLE;INTRAVENOUS 1.5GM/100ML (15MG/ML) Prescription No No AP 2023/01/31 FRESENIUS KABI USA
217059 003 ANDA LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM INJECTABLE;INTRAVENOUS 1.5GM/100ML (15MG/ML) Prescription No No AP 2023/10/02 BAXTER HLTHCARE CORP
211356 003 ANDA LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM INJECTABLE;INTRAVENOUS 1.5GM/100ML (15MG/ML) Prescription No No AP 2024/02/12 HIKMA
209705 003 ANDA LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM INJECTABLE;INTRAVENOUS 1.5GM/100ML (15MG/ML) Prescription No No AP 2024/02/27 B BRAUN MEDICAL
219562 003 ANDA LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM INJECTABLE;INTRAVENOUS 1.5GM/100ML (15MG/ML) Prescription No No AP 2025/01/16 CAPLIN
更多信息
药品NDC数据与药品包装、标签说明书
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