药品注册申请号：204078
申请类型：NDA (新药申请)
申请人：EXELA PHARMA
申请人全名：EXELA PHARMA SCIENCES 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
003 BLOXIVERZ NEOSTIGMINE METHYLSULFATE SOLUTION;INTRAVENOUS 5MG/5ML (1MG/ML) Yes No None 2023/10/27 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
2023/10/27 SUPPL-14（补充） Approval Manufacturing (CMC) N/A
2021/01/19 SUPPL-10（补充） Approval Labeling STANDARD
2015/10/20 SUPPL-7（补充） Approval Labeling STANDARD
2014/12/11 SUPPL-4（补充） Approval Labeling STANDARD
2014/12/02 SUPPL-6（补充） Approval Manufacturing (CMC) STANDARD
2014/09/30 SUPPL-5（补充） Approval Manufacturing (CMC) STANDARD
2014/09/22 SUPPL-3（补充） Approval Manufacturing (CMC) STANDARD
2014/06/18 SUPPL-1（补充） Approval Manufacturing (CMC) STANDARD
2013/05/31 ORIG-1（原始申请） 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
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: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 EXELA PHARMA
207042 001 ANDA NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE SOLUTION;INTRAVENOUS 5MG/10ML (0.5MG/ML) Prescription No No AP 2015/12/28 HIKMA
208405 001 ANDA NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE SOLUTION;INTRAVENOUS 5MG/10ML (0.5MG/ML) Prescription No No AP 2017/04/26 ENDO OPERATIONS
209933 001 ANDA NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE SOLUTION;INTRAVENOUS 5MG/10ML (0.5MG/ML) Prescription No No AP 2017/09/25 AMPHASTAR PHARMS INC
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
212804 001 ANDA NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE SOLUTION;INTRAVENOUS 5MG/10ML (0.5MG/ML) Prescription No No AP 2021/04/05 MEITHEAL
213074 001 ANDA NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE SOLUTION;INTRAVENOUS 5MG/10ML (0.5MG/ML) Prescription No No AP 2021/04/20 CAPLIN
210652 001 ANDA NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE SOLUTION;INTRAVENOUS 5MG/10ML (0.5MG/ML) Prescription No No AP 2021/10/01 ADAPTIS
212627 001 ANDA NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE SOLUTION;INTRAVENOUS 5MG/10ML (0.5MG/ML) Prescription No No AP 2022/11/03 UMEDICA
208230 001 ANDA NEOSTIGMINE METHYSULFATE NEOSTIGMINE METHYLSULFATE SOLUTION;INTRAVENOUS 5MG/10ML (0.5MG/ML) Prescription No No AP 2022/11/25 AVET LIFESCIENCES
216542 001 ANDA NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE SOLUTION;INTRAVENOUS 5MG/10ML (0.5MG/ML) Prescription No No AP 2023/02/17 SAGENT PHARMS INC
213244 001 ANDA NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE SOLUTION;INTRAVENOUS 5MG/10ML (0.5MG/ML) Discontinued No No AP 2023/11/02 EUGIA PHARMA
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 EXELA PHARMA
207042 002 ANDA NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE SOLUTION;INTRAVENOUS 10MG/10ML (1MG/ML) Prescription No No AP 2015/12/28 HIKMA
208405 002 ANDA NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE SOLUTION;INTRAVENOUS 10MG/10ML (1MG/ML) Prescription No No AP 2017/04/26 ENDO OPERATIONS
209933 002 ANDA NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE SOLUTION;INTRAVENOUS 10MG/10ML (1MG/ML) Prescription No No AP 2017/09/25 AMPHASTAR PHARMS INC
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
212804 002 ANDA NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE SOLUTION;INTRAVENOUS 10MG/10ML (1MG/ML) Prescription No No AP 2021/04/05 MEITHEAL
213074 002 ANDA NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE SOLUTION;INTRAVENOUS 10MG/10ML (1MG/ML) Prescription No No AP 2021/04/20 CAPLIN
210652 002 ANDA NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE SOLUTION;INTRAVENOUS 10MG/10ML (1MG/ML) Prescription No No AP 2021/10/01 ADAPTIS
212627 002 ANDA NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE SOLUTION;INTRAVENOUS 10MG/10ML (1MG/ML) Prescription No No AP 2022/11/03 UMEDICA
208230 002 ANDA NEOSTIGMINE METHYSULFATE NEOSTIGMINE METHYLSULFATE SOLUTION;INTRAVENOUS 10MG/10ML (1MG/ML) Prescription No No AP 2022/11/25 AVET LIFESCIENCES
216542 002 ANDA NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE SOLUTION;INTRAVENOUS 10MG/10ML (1MG/ML) Prescription No No AP 2023/02/17 SAGENT PHARMS INC
213244 002 ANDA NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE SOLUTION;INTRAVENOUS 10MG/10ML (1MG/ML) Discontinued No No AP 2023/11/02 EUGIA PHARMA
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药品NDC数据与药品包装、标签说明书
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