药品注册申请号:016964
申请类型:NDA (新药申请)
申请人:HOSPIRA
申请人全名:HOSPIRA INC
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 MARCAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.25% Yes Yes AP 1972/10/03 Approved Prior to Jan 1, 1982 Prescription
004 MARCAINE HYDROCHLORIDE W/ EPINEPHRINE BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE INJECTABLE;INJECTION 0.25%;0.0091MG/ML Yes Yes AP Approved Prior to Jan 1, 1982 Prescription
005 MARCAINE HYDROCHLORIDE PRESERVATIVE FREE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.5% Yes Yes AP Approved Prior to Jan 1, 1982 Prescription
006 MARCAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.5% Yes Yes AP Approved Prior to Jan 1, 1982 Prescription
007 MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE INJECTABLE;INJECTION 0.5%;0.0091MG/ML Yes Yes AP Approved Prior to Jan 1, 1982 Prescription
008 MARCAINE HYDROCHLORIDE W/ EPINEPHRINE BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE INJECTABLE;INJECTION 0.5%;0.0091MG/ML Yes Yes AP Approved Prior to Jan 1, 1982 Prescription
009 MARCAINE HYDROCHLORIDE PRESERVATIVE FREE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.75% Yes Yes AP Approved Prior to Jan 1, 1982 Prescription
010 MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE INJECTABLE;INJECTION 0.75%;0.0091MG/ML Yes Yes AP Approved Prior to Jan 1, 1982 Prescription
012 MARCAINE HYDROCHLORIDE PRESERVATIVE FREE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.25% Yes Yes AP Approved Prior to Jan 1, 1982 Prescription
013 MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE INJECTABLE;INJECTION 0.25%;0.0091MG/ML Yes Yes AP Approved Prior to Jan 1, 1982 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 77 Approval Labeling STANDARD
2014/12/15 SUPPL 73 Approval Manufacturing (CMC) PRIORITY
2014/09/19 SUPPL 72 Approval Manufacturing (CMC) PRIORITY
2013/07/30 SUPPL 71 Approval Manufacturing (CMC) PRIORITY
2012/01/30 SUPPL 70 Approval Labeling STANDARD
2010/02/19 SUPPL 69 Approval Labeling 901 REQUIRED
2005/10/30 SUPPL 61 Approval Labeling STANDARD
2001/01/31 SUPPL 53 Approval Manufacturing (CMC) PRIORITY
1999/03/11 SUPPL 52 Approval Labeling STANDARD
1999/03/11 SUPPL 51 Approval Labeling STANDARD
1999/03/11 SUPPL 48 Approval Labeling STANDARD
1999/03/11 SUPPL 46 Approval Labeling
1997/04/09 SUPPL 50 Approval Manufacturing (CMC) PRIORITY
1993/01/25 SUPPL 47 Approval Manufacturing (CMC) PRIORITY
1991/08/08 SUPPL 45 Approval Labeling
1991/02/06 SUPPL 44 Approval Manufacturing (CMC) PRIORITY
1991/02/06 SUPPL 43 Approval Manufacturing (CMC) PRIORITY
1988/04/27 SUPPL 42 Approval Manufacturing (CMC) PRIORITY
1987/09/15 SUPPL 40 Approval Manufacturing (CMC) PRIORITY
1987/07/13 SUPPL 41 Approval Labeling
1987/01/27 SUPPL 39 Approval Labeling
1987/01/27 SUPPL 38 Approval Manufacturing (CMC) PRIORITY
1985/09/11 SUPPL 35 Approval Labeling
1985/08/24 SUPPL 37 Approval Labeling
1985/08/19 SUPPL 36 Approval Labeling
1985/05/20 SUPPL 31 Approval Manufacturing (CMC) PRIORITY
1984/03/02 SUPPL 25 Approval Manufacturing (CMC) PRIORITY
1983/12/01 SUPPL 34 Approval Labeling
1983/11/21 SUPPL 24 Approval Labeling
1983/07/13 SUPPL 29 Approval Labeling
1983/07/13 SUPPL 28 Approval Manufacturing (CMC) PRIORITY
1983/01/21 SUPPL 30 Approval Manufacturing (CMC) PRIORITY
1982/01/27 SUPPL 20 Approval Manufacturing (CMC) PRIORITY
1981/12/28 SUPPL 23 Approval Labeling
1981/08/21 SUPPL 22 Approval Labeling
1981/08/21 SUPPL 21 Approval Manufacturing (CMC) PRIORITY
1980/11/03 SUPPL 19 Approval Labeling
1980/08/21 SUPPL 15 Approval Labeling
1980/08/21 SUPPL 14 Approval Manufacturing (CMC) PRIORITY
1979/12/06 SUPPL 18 Approval Manufacturing (CMC) PRIORITY
1979/06/18 SUPPL 17 Approval Labeling
1979/04/04 SUPPL 16 Approval Manufacturing (CMC) PRIORITY
1979/04/04 SUPPL 13 Approval Manufacturing (CMC) PRIORITY
1978/06/15 SUPPL 12 Approval Manufacturing (CMC) PRIORITY
1978/06/15 SUPPL 11 Approval Manufacturing (CMC) PRIORITY
1976/11/30 SUPPL 7 Approval Labeling
1976/07/07 SUPPL 8 Approval Manufacturing (CMC) PRIORITY
1976/06/10 SUPPL 6 Approval Manufacturing (CMC) PRIORITY
1976/06/10 SUPPL 4 Approval Labeling
1976/06/07 SUPPL 5 Approval Manufacturing (CMC) PRIORITY
1976/01/13 SUPPL 3 Approval Labeling
1972/10/03 ORIG 1 Approval Type 1 - New Molecular Entity PRIORITY
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; EPINEPHRINE BITARTRATE 剂型/给药途径:INJECTABLE;INJECTION 规格:0.25%;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 004 NDA MARCAINE HYDROCHLORIDE W/ EPINEPHRINE BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE INJECTABLE;INJECTION 0.25%;0.0091MG/ML Prescription Yes Yes AP Approved Prior to Jan 1, 1982 HOSPIRA
016964 013 NDA MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE INJECTABLE;INJECTION 0.25%;0.0091MG/ML Prescription Yes Yes AP Approved Prior to Jan 1, 1982 HOSPIRA
070966 001 ANDA SENSORCAINE BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE INJECTABLE;INJECTION 0.25%;0.0091MG/ML Prescription No No AP 1987/10/13 FRESENIUS KABI USA
070967 001 ANDA SENSORCAINE BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE INJECTABLE;INJECTION 0.25%;0.0091MG/ML Prescription No No AP 1987/10/13 FRESENIUS KABI USA
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:0.5% 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; 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:0.5%;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 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:0.75%;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
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; EPINEPHRINE BITARTRATE 剂型/给药途径:INJECTABLE;INJECTION 规格:0.25%;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 004 NDA MARCAINE HYDROCHLORIDE W/ EPINEPHRINE BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE INJECTABLE;INJECTION 0.25%;0.0091MG/ML Prescription Yes Yes AP Approved Prior to Jan 1, 1982 HOSPIRA
016964 013 NDA MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE INJECTABLE;INJECTION 0.25%;0.0091MG/ML Prescription Yes Yes AP Approved Prior to Jan 1, 1982 HOSPIRA
070966 001 ANDA SENSORCAINE BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE INJECTABLE;INJECTION 0.25%;0.0091MG/ML Prescription No No AP 1987/10/13 FRESENIUS KABI USA
070967 001 ANDA SENSORCAINE BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE INJECTABLE;INJECTION 0.25%;0.0091MG/ML Prescription No No AP 1987/10/13 FRESENIUS KABI USA
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