药品注册申请号：016812
申请类型：NDA (新药申请)
申请人：PH HEALTH
申请人全名：PH HEALTH LTD
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 KETALAR KETAMINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 10MG BASE/ML Yes Yes AP 1970/02/19 Approved Prior to Jan 1, 1982 Prescription
002 KETALAR KETAMINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 50MG BASE/ML Yes No AP Approved Prior to Jan 1, 1982 Prescription
003 KETALAR KETAMINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 100MG BASE/ML Yes 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
1970/02/19 ORIG-1（原始申请） Approval Type 1 - New Molecular Entity PRIORITY
>>>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
2025/10/29 SUPPL-56（补充） Approval Labeling-Package Insert STANDARD
2022/08/23 SUPPL-52（补充） Approval Manufacturing (CMC)-Facility N/A
2022/06/03 SUPPL-51（补充） Approval Labeling-Package Insert STANDARD
2020/08/24 SUPPL-46（补充） Approval Labeling-Package Insert STANDARD
2018/08/07 SUPPL-40（补充） Approval Labeling-Package Insert STANDARD
2017/04/27 SUPPL-43（补充） Approval Labeling-Package Insert STANDARD
2012/03/07 SUPPL-39（补充） Approval Labeling-Package Insert UNKNOWN
2002/11/14 SUPPL-32（补充） Approval Labeling STANDARD
2001/02/14 SUPPL-26（补充） Approval Labeling STANDARD
2000/03/29 SUPPL-30（补充） Approval Manufacturing (CMC)-Control PRIORITY
2000/03/14 SUPPL-29（补充） Approval Labeling STANDARD
1998/11/17 SUPPL-28（补充） Approval Manufacturing (CMC)-Control PRIORITY
1997/09/05 SUPPL-27（补充） Approval Manufacturing (CMC)-Packaging PRIORITY
1994/11/29 SUPPL-25（补充） Approval Manufacturing (CMC)-Packaging PRIORITY
1989/02/07 SUPPL-24（补充） Approval Manufacturing (CMC)-Control PRIORITY
1982/06/11 SUPPL-23（补充） Approval Efficacy
1980/08/18 SUPPL-22（补充） Approval Labeling
1980/04/04 SUPPL-21（补充） Approval Manufacturing (CMC)-Control PRIORITY
1980/04/04 SUPPL-20（补充） Approval Labeling
1977/07/05 SUPPL-19（补充） Approval Labeling
1977/05/16 SUPPL-18（补充） Approval Labeling
1977/05/16 SUPPL-17（补充） Approval Manufacturing (CMC)-Control PRIORITY
1977/01/28 SUPPL-15（补充） Approval Labeling
1976/05/14 SUPPL-14（补充） Approval Labeling
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:KETAMINE HYDROCHLORIDE; 剂型/给药途径:INJECTABLE;INJECTION; 规格:EQ 10MG BASE/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
016812 001 NDA KETALAR KETAMINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 10MG BASE/ML Prescription Yes Yes AP Approved Prior to Jan 1, 1982 PH HEALTH
076092 001 ANDA KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 10MG BASE/ML Prescription No No AP 2008/09/30 EUGIA PHARMA
215808 001 ANDA KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 10MG BASE/ML Prescription No No AP 2023/01/13 FRESENIUS KABI USA
216809 001 ANDA KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 10MG BASE/ML Prescription No No AP 2023/01/24 GLAND
217858 001 ANDA KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 10MG BASE/ML Prescription No No AP 2025/08/07 CAPLIN
>>>活性成分:KETAMINE HYDROCHLORIDE; 剂型/给药途径:INJECTABLE;INJECTION; 规格:EQ 50MG BASE/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
016812 002 NDA KETALAR KETAMINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 50MG BASE/ML Prescription Yes No AP Approved Prior to Jan 1, 1982 PH HEALTH
074524 001 ANDA KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 50MG BASE/ML Prescription No Yes AP 1996/03/22 HIKMA
074549 001 ANDA KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 50MG BASE/ML Prescription No No AP 1996/06/27 HOSPIRA
076092 002 ANDA KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 50MG BASE/ML Prescription No No AP 2001/12/28 EUGIA PHARMA
215808 002 ANDA KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 50MG BASE/ML Prescription No No AP 2023/01/13 FRESENIUS KABI USA
216809 002 ANDA KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 50MG BASE/ML Prescription No No AP 2023/01/24 GLAND
>>>活性成分:KETAMINE HYDROCHLORIDE; 剂型/给药途径:INJECTABLE;INJECTION; 规格:EQ 100MG BASE/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
016812 003 NDA KETALAR KETAMINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 100MG BASE/ML Prescription Yes No AP Approved Prior to Jan 1, 1982 PH HEALTH
074524 002 ANDA KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 100MG BASE/ML Prescription No Yes AP 1996/03/22 HIKMA
074549 002 ANDA KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 100MG BASE/ML Prescription No No AP 1996/06/27 HOSPIRA
076092 003 ANDA KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 100MG BASE/ML Prescription No No AP 2002/10/25 EUGIA PHARMA
216809 003 ANDA KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 100MG BASE/ML Prescription No No AP 2023/01/24 GLAND
215808 003 ANDA KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 100MG BASE/ML Prescription No No AP 2025/04/18 FRESENIUS KABI USA
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药品NDC数据与药品包装、标签说明书
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