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% No No AP 1981/12/30 Approved Prior to Jan 1, 1982 Prescription
002 SENSORCAINE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.5% No No AP Approved Prior to Jan 1, 1982 Prescription
003 SENSORCAINE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.75% No No AP Approved Prior to Jan 1, 1982 Prescription
004 SENSORCAINE BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE INJECTABLE;INJECTION 0.5%;0.0091MG/ML No No AP 1983/09/02 Prescription
005 SENSORCAINE BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE INJECTABLE;INJECTION 0.75%;0.0091MG/ML No No AP 1983/09/02 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
2018/11/02 SUPPL 49 Approval Labeling STANDARD
2016/01/29 SUPPL 40 Approval Manufacturing (CMC)
2015/07/10 SUPPL 45 Approval Labeling STANDARD
2015/07/10 SUPPL 44 Approval Labeling STANDARD
2010/05/17 SUPPL 36 Approval Labeling
2002/12/23 SUPPL 33 Approval Manufacturing (CMC)
2002/03/08 SUPPL 32 Approval Manufacturing (CMC)
2001/06/08 SUPPL 31 Approval Manufacturing (CMC)
2001/06/01 SUPPL 30 Approval Labeling
1999/07/30 SUPPL 29 Approval Manufacturing (CMC)
1997/10/14 SUPPL 24 Approval Manufacturing (CMC)
1997/04/14 SUPPL 28 Approval Manufacturing (CMC)
1996/05/31 SUPPL 27 Approval Manufacturing (CMC)
1994/12/27 SUPPL 23 Approval Manufacturing (CMC)
1993/03/10 SUPPL 20 Approval Manufacturing (CMC)
1992/09/11 SUPPL 21 Approval Manufacturing (CMC)
1992/05/08 SUPPL 19 Approval Manufacturing (CMC)
1991/11/08 SUPPL 18 Approval Manufacturing (CMC)
1991/08/27 SUPPL 16 Approval Labeling
1991/08/27 SUPPL 12 Approval Labeling
1989/10/27 SUPPL 13 Approval Manufacturing (CMC)
1989/08/01 SUPPL 15 Approval Manufacturing (CMC)
1989/08/01 SUPPL 14 Approval Manufacturing (CMC)
1988/05/11 SUPPL 11 Approval Labeling
1987/09/24 SUPPL 9 Approval Manufacturing (CMC)
1981/12/30 ORIG 1 Approval
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: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
018053 002 NDA BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.25% Prescription No No AP Approved Prior to Jan 1, 1982 HOSPIRA
018304 001 NDA SENSORCAINE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.25% Prescription No 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
070586 001 ANDA BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.25% Prescription No No AP 1987/03/03 HOSPIRA
203895 001 ANDA BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.25% Prescription No No AP 2013/11/05 AUROBINDO PHARMA LTD
207183 001 ANDA BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.25% Prescription No No AP 2016/05/13 AUROBINDO PHARMA LTD
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
018053 001 NDA BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.5% Prescription No No AP Approved Prior to Jan 1, 1982 HOSPIRA
018304 002 NDA SENSORCAINE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.5% Prescription No 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
203895 002 ANDA BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.5% Prescription No No AP 2013/11/05 AUROBINDO PHARMA LTD
207183 002 ANDA BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.5% Prescription No No AP 2016/05/13 AUROBINDO PHARMA LTD
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
018053 003 NDA BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.75% Prescription No No AP Approved Prior to Jan 1, 1982 HOSPIRA
018304 003 NDA SENSORCAINE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.75% Prescription No 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
203895 003 ANDA BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.75% Prescription No No AP 2013/11/05 AUROBINDO PHARMA LTD
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 No 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 No No AP 1983/09/02 FRESENIUS KABI USA
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