药品注册申请号:204078
申请类型:NDA (新药申请)
申请人:AVADEL LEGACY
申请人全名:AVADEL LEGACY PHARMACEUTICALS LLC
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 BLOXIVERZ NEOSTIGMINE METHYLSULFATE SOLUTION;INTRAVENOUS 5MG/10ML (0.5MG/ML) Yes Yes AP 2013/05/31 2013/05/31 Prescription
002 BLOXIVERZ NEOSTIGMINE METHYLSULFATE SOLUTION;INTRAVENOUS 10MG/10ML (1MG/ML) Yes Yes AP 2013/05/31 Prescription
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2015/10/20 SUPPL 7 Approval Labeling STANDARD
2014/12/11 SUPPL 4 Approval Labeling STANDARD
2014/12/02 SUPPL 6 Approval Manufacturing (CMC) STANDARD
2014/09/30 SUPPL 5 Approval Manufacturing (CMC) STANDARD
2014/09/22 SUPPL 3 Approval Manufacturing (CMC) STANDARD
2014/06/18 SUPPL 1 Approval Manufacturing (CMC) STANDARD
2013/05/31 ORIG 1 Approval Type 5 - New Formulation or New Manufacturer 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
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:NEOSTIGMINE METHYLSULFATE 剂型/给药途径:SOLUTION;INTRAVENOUS 规格:5MG/10ML (0.5MG/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
204078 001 NDA BLOXIVERZ NEOSTIGMINE METHYLSULFATE SOLUTION;INTRAVENOUS 5MG/10ML (0.5MG/ML) Prescription Yes Yes AP 2013/05/31 AVADEL LEGACY
207042 001 ANDA NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE SOLUTION;INTRAVENOUS 5MG/10ML (0.5MG/ML) Prescription No No AP 2015/12/28 EUROHLTH INTL SARL
208405 001 ANDA NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE SOLUTION;INTRAVENOUS 5MG/10ML (0.5MG/ML) Prescription No No AP 2017/04/26 PAR STERILE PRODUCTS
209933 001 ANDA NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE SOLUTION;INTRAVENOUS 5MG/10ML (0.5MG/ML) Prescription No No AP 2017/09/25 AMPHASTAR PHARMS INC
209182 001 ANDA NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE SOLUTION;INTRAVENOUS 5MG/10ML (0.5MG/ML) Prescription No No AP 2018/05/04 AM REGENT
210051 001 ANDA NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE SOLUTION;INTRAVENOUS 5MG/10ML (0.5MG/ML) Prescription No No AP 2018/06/15 AMNEAL
209135 001 ANDA NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE SOLUTION;INTRAVENOUS 5MG/10ML (0.5MG/ML) Prescription No No AP 2018/07/10 DR REDDYS
210989 001 ANDA NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE SOLUTION;INTRAVENOUS 5MG/10ML (0.5MG/ML) Prescription No No AP 2018/08/22 AMRING PHARMS
212512 001 ANDA NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE SOLUTION;INTRAVENOUS 5MG/10ML (0.5MG/ML) Prescription No No AP 2019/05/13 BE PHARMS
212968 001 ANDA NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE SOLUTION;INTRAVENOUS 5MG/10ML (0.5MG/ML) Prescription No No AP 2019/10/16 GLAND PHARMA LTD
活性成分:NEOSTIGMINE METHYLSULFATE 剂型/给药途径:SOLUTION;INTRAVENOUS 规格:10MG/10ML (1MG/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
204078 002 NDA BLOXIVERZ NEOSTIGMINE METHYLSULFATE SOLUTION;INTRAVENOUS 10MG/10ML (1MG/ML) Prescription Yes Yes AP 2013/05/31 AVADEL LEGACY
207042 002 ANDA NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE SOLUTION;INTRAVENOUS 10MG/10ML (1MG/ML) Prescription No No AP 2015/12/28 EUROHLTH INTL SARL
208405 002 ANDA NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE SOLUTION;INTRAVENOUS 10MG/10ML (1MG/ML) Prescription No No AP 2017/04/26 PAR STERILE PRODUCTS
209933 002 ANDA NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE SOLUTION;INTRAVENOUS 10MG/10ML (1MG/ML) Prescription No No AP 2017/09/25 AMPHASTAR PHARMS INC
209182 002 ANDA NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE SOLUTION;INTRAVENOUS 10MG/10ML (1MG/ML) Prescription No No AP 2018/05/04 AM REGENT
210051 002 ANDA NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE SOLUTION;INTRAVENOUS 10MG/10ML (1MG/ML) Prescription No No AP 2018/06/15 AMNEAL
209135 002 ANDA NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE SOLUTION;INTRAVENOUS 10MG/10ML (1MG/ML) Prescription No No AP 2018/07/10 DR REDDYS
210989 002 ANDA NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE SOLUTION;INTRAVENOUS 10MG/10ML (1MG/ML) Prescription No No AP 2018/08/22 AMRING PHARMS
212512 002 ANDA NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE SOLUTION;INTRAVENOUS 10MG/10ML (1MG/ML) Prescription No No AP 2019/05/13 BE PHARMS
212968 002 ANDA NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE SOLUTION;INTRAVENOUS 10MG/10ML (1MG/ML) Prescription No No AP 2019/10/16 GLAND PHARMA LTD
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