药品注册申请号：017584
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 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 2% No No AP 1976/03/26 Approved Prior to Jan 1, 1982 Prescription
002 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 4% No No AP Approved Prior to Jan 1, 1982 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
1996/09/13 SUPPL-28（补充） Approval Labeling STANDARD
1995/12/19 SUPPL-25（补充） Approval Manufacturing (CMC) STANDARD
1995/12/19 SUPPL-24（补充） Approval Manufacturing (CMC) STANDARD
1994/08/05 SUPPL-19（补充） Approval Labeling
1993/05/17 SUPPL-27（补充） Approval Labeling STANDARD
1991/08/23 SUPPL-22（补充） Approval Manufacturing (CMC) STANDARD
1987/04/07 SUPPL-21（补充） Approval Manufacturing (CMC) STANDARD
1986/05/22 SUPPL-16（补充） Approval Labeling
1986/02/24 SUPPL-18（补充） Approval Manufacturing (CMC) STANDARD
1986/02/14 SUPPL-15（补充） Approval Labeling
1985/04/30 SUPPL-14（补充） Approval Manufacturing (CMC) STANDARD
1984/08/31 SUPPL-17（补充） Approval Manufacturing (CMC) STANDARD
1982/12/08 SUPPL-12（补充） Approval Manufacturing (CMC) STANDARD
1982/07/21 SUPPL-13（补充） Approval Labeling
1981/02/05 SUPPL-11（补充） Approval Manufacturing (CMC) STANDARD
1980/01/09 SUPPL-10（补充） Approval Labeling
1979/07/10 SUPPL-9（补充） Approval Manufacturing (CMC) STANDARD
1978/05/26 SUPPL-5（补充） Approval Manufacturing (CMC) STANDARD
1978/05/26 SUPPL-4（补充） Approval Labeling
1977/12/01 SUPPL-8（补充） Approval Manufacturing (CMC) STANDARD
1977/12/01 SUPPL-7（补充） Approval Manufacturing (CMC) STANDARD
1977/07/12 SUPPL-6（补充） Approval Manufacturing (CMC) STANDARD
1976/10/29 SUPPL-3（补充） Approval Labeling
1976/08/18 SUPPL-2（补充） Approval Labeling
1976/06/08 SUPPL-1（补充） Approval Manufacturing (CMC) STANDARD
1976/03/26 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: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
080404 003 ANDA LIDOCAINE HYDROCHLORIDE 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 WEST-WARD PHARMS INT
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
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:LIDOCAINE HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:4% 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
017584 002 NDA LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 4% Prescription No No AP Approved Prior to Jan 1, 1982 FRESENIUS KABI USA
088295 001 ANDA LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 4% Prescription No Yes AP 1984/05/17 HOSPIRA
214269 001 ANDA LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 4% Prescription No No AP 2022/05/05 SINTETICA US
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药品NDC数据与药品包装、标签说明书
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