药品注册申请号：006488
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
002 XYLOCAINE LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 2% Yes Yes AP 1948/11/19 Approved Prior to Jan 1, 1982 Prescription
003 XYLOCAINE W/ EPINEPHRINE EPINEPHRINE; LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.01MG/ML;2% Yes No None Approved Prior to Jan 1, 1982 Discontinued
004 XYLOCAINE W/ EPINEPHRINE EPINEPHRINE; LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.01MG/ML;1% Yes Yes AP Approved Prior to Jan 1, 1982 Prescription
005 XYLOCAINE W/ EPINEPHRINE EPINEPHRINE; LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.02MG/ML;2% Yes Yes AP Approved Prior to Jan 1, 1982 Prescription
007 XYLOCAINE LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 1% Yes Yes AP Approved Prior to Jan 1, 1982 Prescription
008 XYLOCAINE LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.5% Yes Yes AP Approved Prior to Jan 1, 1982 Prescription
010 XYLOCAINE LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 1.5% Yes Yes AP Approved Prior to Jan 1, 1982 Prescription
012 XYLOCAINE W/ EPINEPHRINE EPINEPHRINE; LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.005MG/ML;0.5% Yes Yes AP Approved Prior to Jan 1, 1982 Prescription
017 XYLOCAINE W/ EPINEPHRINE EPINEPHRINE; LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.005MG/ML;1.5% Yes Yes AP Approved Prior to Jan 1, 1982 Prescription
018 XYLOCAINE W/ EPINEPHRINE EPINEPHRINE; LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.005MG/ML;1% Yes Yes None 1986/11/13 Prescription
019 XYLOCAINE W/ EPINEPHRINE EPINEPHRINE; LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.005MG/ML;2% Yes Yes AP 1986/11/13 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
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
2024/10/30 SUPPL-100（补充） Approval Labeling STANDARD
2018/11/02 SUPPL-97（补充） Approval Labeling STANDARD
2017/12/22 SUPPL-95（补充） Approval Manufacturing (CMC) STANDARD
2017/12/22 SUPPL-90（补充） Approval Labeling STANDARD
2016/03/17 SUPPL-91（补充） Approval Manufacturing (CMC)
2015/03/03 SUPPL-89（补充） Approval Manufacturing (CMC)
2013/12/26 SUPPL-88（补充） Approval Manufacturing (CMC)
2013/10/29 SUPPL-79（补充） Approval Manufacturing (CMC)
2013/07/22 SUPPL-87（补充） Approval Manufacturing (CMC)
2013/06/11 SUPPL-76（补充） Approval Manufacturing (CMC)
2013/04/09 SUPPL-78（补充） Approval Manufacturing (CMC)
2013/03/28 SUPPL-84（补充） Approval Labeling STANDARD
2013/02/20 SUPPL-86（补充） Approval Manufacturing (CMC)
2013/02/16 SUPPL-83（补充） Approval Manufacturing (CMC)
2013/02/13 SUPPL-85（补充） Approval Manufacturing (CMC)
2010/02/19 SUPPL-74（补充） Approval Labeling 901 REQUIRED
2002/07/17 SUPPL-66（补充） Approval Manufacturing (CMC)
2000/12/14 SUPPL-64（补充） Approval Manufacturing (CMC)
2000/12/08 SUPPL-65（补充） Approval Manufacturing (CMC)
1999/05/26 SUPPL-61（补充） Approval Labeling STANDARD
1998/03/06 SUPPL-62（补充） Approval Manufacturing (CMC)
1997/12/08 SUPPL-57（补充） Approval Manufacturing (CMC)
1996/05/31 SUPPL-59（补充） Approval Manufacturing (CMC)
1996/05/02 SUPPL-60（补充） Approval Manufacturing (CMC)
1996/01/03 SUPPL-58（补充） Approval Manufacturing (CMC)
1995/07/18 SUPPL-56（补充） Approval Manufacturing (CMC)
1995/07/11 SUPPL-55（补充） Approval Manufacturing (CMC)
1994/11/21 SUPPL-54（补充） Approval Manufacturing (CMC)
1993/10/20 SUPPL-51（补充） Approval Manufacturing (CMC)
1993/04/13 SUPPL-53（补充） Approval Manufacturing (CMC)
1993/02/18 SUPPL-52（补充） Approval Manufacturing (CMC)
1991/03/21 SUPPL-36（补充） Approval Labeling
1991/03/21 SUPPL-35（补充） Approval Manufacturing (CMC)
1990/10/02 SUPPL-50（补充） Approval Manufacturing (CMC)
1989/07/11 SUPPL-49（补充） Approval Manufacturing (CMC)
1988/12/02 SUPPL-48（补充） Approval Labeling
1988/12/02 SUPPL-47（补充） Approval Manufacturing (CMC)
1987/09/16 SUPPL-43（补充） Approval Manufacturing (CMC)
1987/09/11 SUPPL-46（补充） Approval Labeling
1987/09/11 SUPPL-45（补充） Approval Manufacturing (CMC)
1987/03/18 SUPPL-44（补充） Approval Labeling
1986/11/13 SUPPL-38（补充） Approval Labeling
1986/11/13 SUPPL-37（补充） Approval Manufacturing (CMC)
1986/08/29 SUPPL-40（补充） Approval Labeling
1986/08/29 SUPPL-39（补充） Approval Manufacturing (CMC)
1986/05/19 SUPPL-42（补充） Approval Labeling
1986/02/27 SUPPL-41（补充） Approval Labeling
1986/02/22 SUPPL-29（补充） Approval Labeling
1986/02/22 SUPPL-28（补充） Approval Manufacturing (CMC)
1985/03/22 SUPPL-34（补充） Approval Labeling
1985/03/22 SUPPL-33（补充） Approval Manufacturing (CMC)
1984/12/12 SUPPL-27（补充） Approval Labeling
1984/12/03 SUPPL-32（补充） Approval Labeling
1982/07/26 SUPPL-25（补充） Approval Labeling
1982/07/26 SUPPL-24（补充） Approval Manufacturing (CMC)
1982/06/28 SUPPL-31（补充） Approval Manufacturing (CMC)
1982/03/25 SUPPL-30（补充） Approval Manufacturing (CMC)
1981/10/01 SUPPL-26（补充） Approval Labeling
1981/10/01 SUPPL-23（补充） Approval Manufacturing (CMC)
1980/12/31 SUPPL-20（补充） Approval Labeling
1980/04/17 SUPPL-22（补充） Approval Manufacturing (CMC)
1979/08/29 SUPPL-21（补充） Approval Labeling
1979/04/09 SUPPL-18（补充） Approval Labeling
1979/04/09 SUPPL-17（补充） Approval Manufacturing (CMC)
1979/03/26 SUPPL-16（补充） Approval Manufacturing (CMC)
1979/02/27 SUPPL-19（补充） Approval Manufacturing (CMC)
1978/05/17 SUPPL-15（补充） Approval Labeling
1976/02/02 SUPPL-13（补充） Approval Manufacturing (CMC)
1975/10/09 SUPPL-11（补充） Approval Labeling
1975/08/28 SUPPL-9（补充） Approval Manufacturing (CMC)
1975/08/28 SUPPL-8（补充） Approval Labeling
1975/07/16 SUPPL-10（补充） Approval Manufacturing (CMC)
1974/06/24 SUPPL-6（补充） Approval Supplement
1974/05/20 SUPPL-5（补充） Approval Manufacturing (CMC)
1972/12/04 SUPPL-2（补充） Approval Labeling
1948/11/19 ORIG-1（原始申请） Approval UNKNOWN
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:LIDOCAINE HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:2% 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
006488 002 NDA XYLOCAINE LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 2% Prescription Yes Yes AP Approved Prior to Jan 1, 1982 FRESENIUS KABI USA
017584 001 NDA LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 2% Prescription No No AP Approved Prior to Jan 1, 1982 FRESENIUS KABI USA
080407 002 ANDA LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 2% Prescription No No AP Approved Prior to Jan 1, 1982 WEST-WARD PHARMS INT
083158 002 ANDA LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 2% Prescription Yes Yes AP Approved Prior to Jan 1, 1982 HOSPIRA
083173 002 ANDA LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 2% Prescription No No AP Approved Prior to Jan 1, 1982 INTL MEDICATION
084625 002 ANDA LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 2% Prescription No No AP Approved Prior to Jan 1, 1982 HIKMA
088586 003 ANDA LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 2% Prescription No No AP Approved Prior to Jan 1, 1982 FRESENIUS KABI USA
088294 001 ANDA LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 2% Prescription No No AP 1984/05/17 HOSPIRA
088327 001 ANDA LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 2% Prescription No No AP 1984/07/31 HOSPIRA
040078 001 ANDA LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 2% Prescription No No AP 1995/06/23 HOSPIRA
040302 002 ANDA LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE IN PLASTIC CONTAINER LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 2% Prescription No No AP 1998/09/28 HOSPIRA
203040 002 ANDA LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 2% Prescription No No AP 2013/03/14 EUGIA PHARMA
203082 002 ANDA LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 2% Prescription No No AP 2013/03/14 EUGIA PHARMA
207182 002 ANDA LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 2% Prescription No No AP 2017/10/30 EUGIA PHARMA
214339 002 ANDA LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 2% Prescription No No AP 2021/11/08 ASPIRO
214267 002 ANDA LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 2% Prescription No No AP 2022/09/19 SINTETICA US
212821 002 ANDA LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 2% Prescription No No AP 2023/06/15 HUONS
217692 002 ANDA LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 2% Prescription No No AP 2023/06/16 MANKIND PHARMA
217693 002 ANDA LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 2% Prescription No No AP 2023/07/11 MANKIND PHARMA
214336 002 ANDA LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 2% Prescription No No AP 2023/12/13 ASPIRO
活性成分:EPINEPHRINE; LIDOCAINE HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:0.01MG/ML;1% 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
006488 004 NDA XYLOCAINE W/ EPINEPHRINE EPINEPHRINE; LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.01MG/ML;1% Prescription Yes Yes AP Approved Prior to Jan 1, 1982 FRESENIUS KABI USA
089644 001 ANDA LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE EPINEPHRINE; LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.01MG/ML;1% Prescription No No AP 1988/06/21 HOSPIRA
活性成分:EPINEPHRINE; LIDOCAINE HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:0.02MG/ML;2% 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
006488 005 NDA XYLOCAINE W/ EPINEPHRINE EPINEPHRINE; LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.02MG/ML;2% Prescription Yes Yes AP Approved Prior to Jan 1, 1982 FRESENIUS KABI USA
活性成分:LIDOCAINE HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:1% 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
080407 001 ANDA LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 1% Prescription No No AP Approved Prior to Jan 1, 1982 WEST-WARD PHARMS INT
080408 001 ANDA LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 1% Prescription No No AP Approved Prior to Jan 1, 1982 HOSPIRA
083158 001 ANDA LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 1% Prescription Yes Yes AP Approved Prior to Jan 1, 1982 HOSPIRA
083173 001 ANDA LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 1% Prescription Yes No AP Approved Prior to Jan 1, 1982 INTL MEDICATION
084625 001 ANDA LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 1% Prescription No No AP Approved Prior to Jan 1, 1982 HIKMA
006488 007 NDA XYLOCAINE LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 1% Prescription Yes Yes AP Approved Prior to Jan 1, 1982 FRESENIUS KABI USA
088586 002 ANDA LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 1% Prescription No No AP Approved Prior to Jan 1, 1982 FRESENIUS KABI USA
088329 001 ANDA LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 1% Prescription No No AP 1984/05/17 HOSPIRA
088299 001 ANDA LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 1% Prescription No No AP 1984/07/31 HOSPIRA
088586 001 ANDA LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 1% Prescription No No AP 1985/07/24 FRESENIUS KABI USA
040302 001 ANDA LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE IN PLASTIC CONTAINER LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 1% Prescription No No AP 1998/09/28 HOSPIRA
203040 001 ANDA LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 1% Prescription No No AP 2013/03/14 EUGIA PHARMA
203082 001 ANDA LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 1% Prescription No No AP 2013/03/14 EUGIA PHARMA
207182 001 ANDA LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 1% Prescription No No AP 2017/10/30 EUGIA PHARMA
208017 001 ANDA LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 1% Prescription No No AP 2018/04/18 SPECTRA MDCL DEVICES
208474 001 ANDA LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 1% Prescription No No AP 2018/08/03 B BRAUN MEDICAL INC
212821 001 ANDA LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 1% Prescription No No AP 2020/05/07 HUONS
214336 001 ANDA LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 1% Prescription No No AP 2021/11/08 ASPIRO
214339 001 ANDA LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 1% Prescription No No AP 2021/11/08 ASPIRO
215132 001 ANDA LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 1% Prescription No No AP 2022/06/09 AFAXYS
214267 001 ANDA LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 1% Prescription No No AP 2022/09/19 SINTETICA US
217692 001 ANDA LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 1% Prescription No No AP 2023/06/16 MANKIND PHARMA
217693 001 ANDA LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 1% Prescription No No AP 2023/07/11 MANKIND PHARMA
217692 003 ANDA LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 1% Prescription No No AP 2023/11/29 MANKIND PHARMA
活性成分:LIDOCAINE 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
006488 008 NDA XYLOCAINE LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.5% Prescription Yes Yes AP Approved Prior to Jan 1, 1982 FRESENIUS KABI USA
088328 001 ANDA LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.5% Prescription No No AP 1984/05/17 HOSPIRA
088325 001 ANDA LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.5% Prescription No No AP 1984/07/31 HOSPIRA
活性成分:LIDOCAINE HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:1.5% 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
006488 010 NDA XYLOCAINE LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 1.5% Prescription Yes Yes AP Approved Prior to Jan 1, 1982 FRESENIUS KABI USA
080408 002 ANDA LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 1.5% Prescription No No AP Approved Prior to Jan 1, 1982 HOSPIRA
活性成分:EPINEPHRINE; LIDOCAINE HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:0.005MG/ML;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
006488 012 NDA XYLOCAINE W/ EPINEPHRINE EPINEPHRINE; LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.005MG/ML;0.5% Prescription Yes Yes AP Approved Prior to Jan 1, 1982 FRESENIUS KABI USA
089635 001 ANDA LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE EPINEPHRINE; LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.005MG/ML;0.5% Prescription No No AP 1988/06/21 HOSPIRA
活性成分:EPINEPHRINE; LIDOCAINE HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:0.005MG/ML;1.5% 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
006488 017 NDA XYLOCAINE W/ EPINEPHRINE EPINEPHRINE; LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.005MG/ML;1.5% Prescription Yes Yes AP Approved Prior to Jan 1, 1982 FRESENIUS KABI USA
088571 001 ANDA LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE EPINEPHRINE; LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.005MG/ML;1.5% Prescription No No AP 1985/09/13 HOSPIRA
089645 001 ANDA LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE EPINEPHRINE; LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.005MG/ML;1.5% Prescription No No AP 1988/06/21 HOSPIRA
208475 001 ANDA LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE EPINEPHRINE; LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.005MG/ML;1.5% Prescription No No AP 2021/09/08 B BRAUN MEDICAL INC
活性成分:EPINEPHRINE; LIDOCAINE HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:0.005MG/ML;2% 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
006488 019 NDA XYLOCAINE W/ EPINEPHRINE EPINEPHRINE; LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.005MG/ML;2% Prescription Yes Yes AP 1986/11/13 FRESENIUS KABI USA
089651 001 ANDA LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE EPINEPHRINE; LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.005MG/ML;2% Prescription No No AP 1988/06/21 HOSPIRA
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