药品注册申请号：018304
申请类型：NDA (新药申请)
申请人：FRESENIUS KABI USA
申请人全名：FRESENIUS KABI USA 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 SENSORCAINE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.25% Yes No AP 1981/12/30 Approved Prior to Jan 1, 1982 Prescription
002 SENSORCAINE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.5% Yes No AP Approved Prior to Jan 1, 1982 Prescription
003 SENSORCAINE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.75% Yes No AP Approved Prior to Jan 1, 1982 Prescription
004 SENSORCAINE BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE INJECTABLE;INJECTION 0.5%;0.0091MG/ML Yes No AP 1983/09/02 Prescription
005 SENSORCAINE BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE INJECTABLE;INJECTION 0.75%;0.0091MG/ML Yes No AP 1983/09/02 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
1981/12/30 ORIG-1（原始申请） Approval
>>>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
2022/07/19 SUPPL-50（补充） Approval Labeling-Package Insert STANDARD
2018/11/02 SUPPL-49（补充） Approval Labeling-Package Insert STANDARD
2016/01/29 SUPPL-40（补充） Approval Manufacturing (CMC)
2015/07/10 SUPPL-45（补充） Approval Labeling-Package Insert,Labeling-Package Insert STANDARD
2015/07/10 SUPPL-44（补充） Approval Labeling-Package Insert STANDARD
2010/05/17 SUPPL-36（补充） Approval Labeling-Package Insert
2002/12/23 SUPPL-33（补充） Approval Manufacturing (CMC)-Microbiology-Processing
2002/03/08 SUPPL-32（补充） Approval Manufacturing (CMC)-Microbiology-Processing
2001/06/08 SUPPL-31（补充） Approval Manufacturing (CMC)-Control
2001/06/01 SUPPL-30（补充） Approval Labeling
1999/07/30 SUPPL-29（补充） Approval Manufacturing (CMC)
1997/10/14 SUPPL-24（补充） Approval Manufacturing (CMC)
1997/04/14 SUPPL-28（补充） Approval Manufacturing (CMC)
1996/05/31 SUPPL-27（补充） Approval Manufacturing (CMC)
1994/12/27 SUPPL-23（补充） Approval Manufacturing (CMC)-Microbiology-Processing
1993/03/10 SUPPL-20（补充） Approval Manufacturing (CMC)
1992/09/11 SUPPL-21（补充） Approval Manufacturing (CMC)
1992/05/08 SUPPL-19（补充） Approval Manufacturing (CMC)
1991/11/08 SUPPL-18（补充） Approval Manufacturing (CMC)
1991/08/27 SUPPL-16（补充） Approval Labeling
1991/08/27 SUPPL-12（补充） Approval Labeling
1989/10/27 SUPPL-13（补充） Approval Manufacturing (CMC)
1989/08/01 SUPPL-15（补充） Approval Manufacturing (CMC)
1989/08/01 SUPPL-14（补充） Approval Manufacturing (CMC)
1988/05/11 SUPPL-11（补充） Approval Labeling
1987/09/24 SUPPL-9（补充） Approval Manufacturing (CMC)
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:BUPIVACAINE HYDROCHLORIDE; 剂型/给药途径:INJECTABLE;INJECTION; 规格:0.25%; 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
016964 001 NDA MARCAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.25% Prescription Yes Yes AP Approved Prior to Jan 1, 1982 HOSPIRA
016964 012 NDA MARCAINE HYDROCHLORIDE PRESERVATIVE FREE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.25% Prescription Yes Yes AP Approved Prior to Jan 1, 1982 HOSPIRA
018304 001 NDA SENSORCAINE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.25% Prescription Yes No AP Approved Prior to Jan 1, 1982 FRESENIUS KABI USA
070552 001 ANDA SENSORCAINE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.25% Prescription No No AP 1986/05/21 FRESENIUS KABI USA
070583 001 ANDA BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.25% Prescription No No AP 1987/02/17 HOSPIRA
070590 001 ANDA BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.25% Prescription No No AP 1987/02/17 HOSPIRA
091487 002 ANDA BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.25% Prescription No No AP 2011/10/18 ONESOURCE SPECIALTY
091503 001 ANDA BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.25% Prescription No No AP 2011/10/18 ONESOURCE SPECIALTY
203895 001 ANDA BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.25% Prescription No No AP 2013/11/05 EUGIA PHARMA
207183 001 ANDA BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.25% Prescription No No AP 2016/05/13 EUGIA PHARMA
204842 001 ANDA BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.25% Prescription No No AP 2021/02/11 HIKMA PHARMS
205141 001 ANDA BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.25% Prescription No No AP 2021/02/11 HIKMA PHARMS
216039 001 ANDA BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.25% Prescription No No AP 2023/06/23 MEITHEAL
217792 001 ANDA BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.25% Prescription No No AP 2023/11/20 SOMERSET
216040 001 ANDA BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.25% Prescription No No AP 2023/12/27 MEITHEAL
217821 001 ANDA BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.25% Prescription No No AP 2024/03/27 ASPIRO
>>>活性成分:BUPIVACAINE HYDROCHLORIDE; 剂型/给药途径:INJECTABLE;INJECTION; 规格:0.5%; 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
016964 005 NDA MARCAINE HYDROCHLORIDE PRESERVATIVE FREE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.5% Prescription Yes Yes AP Approved Prior to Jan 1, 1982 HOSPIRA
016964 006 NDA MARCAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.5% Prescription Yes Yes AP Approved Prior to Jan 1, 1982 HOSPIRA
018304 002 NDA SENSORCAINE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.5% Prescription Yes No AP Approved Prior to Jan 1, 1982 FRESENIUS KABI USA
070584 001 ANDA BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.5% Prescription No No AP 1986/02/17 HOSPIRA
070553 001 ANDA SENSORCAINE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.5% Prescription No No AP 1986/05/21 FRESENIUS KABI USA
070597 001 ANDA BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.5% Prescription No No AP 1987/03/03 HOSPIRA
070609 001 ANDA BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.5% Prescription No No AP 1987/03/03 HOSPIRA
091487 001 ANDA BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.5% Prescription No No AP 2011/10/18 ONESOURCE SPECIALTY
091503 002 ANDA BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.5% Prescription No No AP 2011/10/18 ONESOURCE SPECIALTY
203895 002 ANDA BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.5% Prescription No No AP 2013/11/05 EUGIA PHARMA
207183 002 ANDA BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.5% Prescription No No AP 2016/05/13 EUGIA PHARMA
204842 002 ANDA BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.5% Prescription No No AP 2021/02/11 HIKMA PHARMS
205141 002 ANDA BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.5% Prescription No No AP 2021/02/11 HIKMA PHARMS
216039 002 ANDA BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.5% Prescription No No AP 2023/06/23 MEITHEAL
217792 002 ANDA BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.5% Prescription No No AP 2023/11/20 SOMERSET
216040 002 ANDA BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.5% Prescription No No AP 2023/12/27 MEITHEAL
217821 002 ANDA BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.5% Prescription No No AP 2024/03/27 ASPIRO
>>>活性成分:BUPIVACAINE HYDROCHLORIDE; 剂型/给药途径:INJECTABLE;INJECTION; 规格:0.75%; 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
016964 009 NDA MARCAINE HYDROCHLORIDE PRESERVATIVE FREE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.75% Prescription Yes Yes AP Approved Prior to Jan 1, 1982 HOSPIRA
018304 003 NDA SENSORCAINE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.75% Prescription Yes No AP Approved Prior to Jan 1, 1982 FRESENIUS KABI USA
070554 001 ANDA SENSORCAINE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.75% Prescription No No AP 1986/05/21 FRESENIUS KABI USA
070585 001 ANDA BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.75% Prescription No No AP 1987/03/03 HOSPIRA
091487 003 ANDA BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.75% Prescription No No AP 2011/10/18 ONESOURCE SPECIALTY
203895 003 ANDA BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.75% Prescription No No AP 2013/11/05 EUGIA PHARMA
204842 003 ANDA BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.75% Prescription No No AP 2021/02/11 HIKMA PHARMS
216040 003 ANDA BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.75% Prescription No No AP 2023/12/27 MEITHEAL
217821 003 ANDA BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.75% Prescription No No AP 2024/03/27 ASPIRO
>>>活性成分:BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE; 剂型/给药途径:INJECTABLE;INJECTION; 规格:0.5%;0.0091MG/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
016964 007 NDA MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE INJECTABLE;INJECTION 0.5%;0.0091MG/ML Prescription Yes Yes AP Approved Prior to Jan 1, 1982 HOSPIRA
016964 008 NDA MARCAINE HYDROCHLORIDE W/ EPINEPHRINE BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE INJECTABLE;INJECTION 0.5%;0.0091MG/ML Prescription Yes Yes AP Approved Prior to Jan 1, 1982 HOSPIRA
018304 004 NDA SENSORCAINE BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE INJECTABLE;INJECTION 0.5%;0.0091MG/ML Prescription Yes No AP 1983/09/02 FRESENIUS KABI USA
070968 001 ANDA SENSORCAINE BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE INJECTABLE;INJECTION 0.5%;0.0091MG/ML Prescription No No AP 1987/10/13 FRESENIUS KABI USA
>>>活性成分:BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE; 剂型/给药途径:INJECTABLE;INJECTION; 规格:0.75%;0.0091MG/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
016964 010 NDA MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE INJECTABLE;INJECTION 0.75%;0.0091MG/ML Prescription Yes Yes AP Approved Prior to Jan 1, 1982 HOSPIRA
018304 005 NDA SENSORCAINE BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE INJECTABLE;INJECTION 0.75%;0.0091MG/ML Prescription Yes No AP 1983/09/02 FRESENIUS KABI USA
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