药品注册申请号：202543
申请类型：NDA (新药申请)
申请人：HQ SPCLT PHARMA
申请人全名：HQ SPECIALTY PHARMA CORP
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) Yes Yes AP 2011/11/09 2011/11/09 Prescription
002 LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM INJECTABLE;INTRAVENOUS 1GM/100ML (10MG/ML) Yes Yes AP 2011/11/09 Prescription
003 LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM INJECTABLE;INTRAVENOUS 1.5GM/100ML (15MG/ML) Yes Yes AP 2011/11/09 Prescription
004 LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM INJECTABLE;INTRAVENOUS 250MG/50ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 2020/12/14 Discontinued
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
2024/03/12 SUPPL-24（补充） Approval Labeling STANDARD
2021/04/13 SUPPL-19（补充） Approval Labeling STANDARD
2019/11/21 SUPPL-15（补充） Approval Labeling STANDARD
2018/07/12 SUPPL-11（补充） Approval Labeling STANDARD
2017/06/12 SUPPL-10（补充） Approval Labeling STANDARD
2016/11/18 SUPPL-9（补充） Approval Labeling STANDARD
2016/11/18 SUPPL-8（补充） Approval Labeling STANDARD
2015/07/14 SUPPL-6（补充） Approval Manufacturing (CMC) STANDARD
2015/02/03 SUPPL-5（补充） Approval Manufacturing (CMC) STANDARD
2013/10/04 SUPPL-4（补充） Approval Manufacturing (CMC) STANDARD
2013/08/07 SUPPL-3（补充） Approval Manufacturing (CMC) STANDARD
2012/11/09 SUPPL-2（补充） Approval Manufacturing (CMC) STANDARD
2011/11/09 ORIG-1（原始申请） Approval Type 3 - New Dosage Form 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 PHARMA LTD
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) Discontinued 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 INC
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 PHARMA LTD
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) Discontinued 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 INC
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 PHARMA LTD
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) Discontinued 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 INC
更多信息
药品NDC数据与药品包装、标签说明书
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