药品注册申请号：080408
申请类型：ANDA (仿制药申请)
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 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 1% No No AP 1972/09/28 Approved Prior to Jan 1, 1982 Prescription
002 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 1.5% 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
>>>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
1972/09/28 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
2020/03/19 SUPPL-61（补充） Approval Labeling-Package Insert STANDARD
2020/03/19 SUPPL-58（补充） Approval Labeling-Package Insert STANDARD
2010/04/16 SUPPL-48（补充） Approval Labeling-Package Insert
2002/01/02 SUPPL-31（补充） Approval Labeling
1997/02/24 SUPPL-30（补充） Approval Manufacturing (CMC)-Microbiology-Processing
1996/10/03 SUPPL-29（补充） Approval Manufacturing (CMC)-Microbiology-Processing
1990/09/28 SUPPL-26（补充） Approval Labeling
1989/06/13 SUPPL-27（补充） Approval Manufacturing (CMC)
1988/11/28 SUPPL-25（补充） Approval Labeling
1986/07/25 SUPPL-24（补充） Approval Manufacturing (CMC)
1985/08/09 SUPPL-23（补充） Approval Manufacturing (CMC)
1982/09/14 SUPPL-21（补充） Approval Manufacturing (CMC)
1982/09/14 SUPPL-20（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: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% Discontinued 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
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% Discontinued No No AP 2022/06/09 AFAXYS
214267 001 ANDA LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 1% Prescription No No AP 2022/09/19 YILING
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
219535 001 ANDA LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 1% Prescription No No AP 2025/04/02 ANTHEA PHARMA
>>>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
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