药品注册申请号：018248
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 OXYTOCIN OXYTOCIN INJECTABLE;INJECTION 10USP UNITS/ML (10USP UNITS/ML) Yes Yes AP 1980/07/09 Approved Prior to Jan 1, 1982 Prescription
002 OXYTOCIN OXYTOCIN INJECTABLE;INJECTION 100USP UNITS/10ML (10USP UNITS/ML) Yes Yes AP Approved Prior to Jan 1, 1982 Prescription
003 OXYTOCIN OXYTOCIN INJECTABLE;INJECTION 300USP UNITS/30ML (10USP UNITS/ML) Yes Yes None 2007/07/27 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
1980/07/09 ORIG-1（原始申请） Approval Type 5 - New Formulation or New Manufacturer STANDARD
>>>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
2022/09/20 SUPPL-49（补充） Approval Labeling-Package Insert,Labeling-Container/Carton Labels STANDARD
2014/09/10 SUPPL-42（补充） Approval Manufacturing (CMC) STANDARD
2007/07/27 SUPPL-34（补充） Approval Labeling-Container/Carton Labels,Labeling-Package Insert N/A
2000/10/11 SUPPL-28（补充） Approval Manufacturing (CMC)-Expiration Date STANDARD
2000/05/31 SUPPL-27（补充） Approval Labeling STANDARD
1999/07/02 SUPPL-25（补充） Approval Manufacturing (CMC)-Control STANDARD
1999/02/22 SUPPL-26（补充） Approval Labeling STANDARD
1999/01/20 SUPPL-19（补充） Approval Manufacturing (CMC) STANDARD
1997/10/17 SUPPL-24（补充） Approval Manufacturing (CMC) STANDARD
1995/01/13 SUPPL-22（补充） Approval Manufacturing (CMC)-Control STANDARD
1994/12/16 SUPPL-20（补充） Approval Manufacturing (CMC)-Control STANDARD
1994/11/23 SUPPL-23（补充） Approval Labeling STANDARD
1988/02/16 SUPPL-18（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1987/02/24 SUPPL-17（补充） Approval Labeling
1986/10/14 SUPPL-15（补充） Approval Labeling
1986/09/19 SUPPL-16（补充） Approval Manufacturing (CMC)-Control STANDARD
1985/03/14 SUPPL-14（补充） Approval Manufacturing (CMC)-Control STANDARD
1984/07/23 SUPPL-13（补充） Approval Manufacturing (CMC)-Control STANDARD
1983/11/08 SUPPL-12（补充） Approval Manufacturing (CMC)-Control STANDARD
1983/08/10 SUPPL-11（补充） Approval Labeling
1983/04/14 SUPPL-8（补充） Approval Labeling
1982/11/12 SUPPL-9（补充） Approval Manufacturing (CMC)-Control STANDARD
1982/03/10 SUPPL-7（补充） Approval Manufacturing (CMC) 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:OXYTOCIN; 剂型/给药途径:INJECTABLE;INJECTION; 规格:10USP UNITS/ML (10USP UNITS/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
018243 001 NDA OXYTOCIN OXYTOCIN INJECTABLE;INJECTION 10USP UNITS/ML (10USP UNITS/ML) Prescription Yes Yes AP Approved Prior to Jan 1, 1982 HIKMA
018248 001 NDA OXYTOCIN OXYTOCIN INJECTABLE;INJECTION 10USP UNITS/ML (10USP UNITS/ML) Prescription Yes Yes AP Approved Prior to Jan 1, 1982 FRESENIUS KABI USA
018261 001 NDA PITOCIN OXYTOCIN INJECTABLE;INJECTION 10USP UNITS/ML (10USP UNITS/ML) Prescription Yes Yes AP Approved Prior to Jan 1, 1982 PH HEALTH
200219 001 ANDA OXYTOCIN OXYTOCIN INJECTABLE;INJECTION 10USP UNITS/ML (10USP UNITS/ML) Prescription No No AP 2013/02/13 HIKMA FARMACEUTICA
091676 001 ANDA OXYTOCIN OXYTOCIN INJECTABLE;INJECTION 10USP UNITS/ML (10USP UNITS/ML) Prescription No No AP 2018/07/13 SAGENT PHARMS INC
>>>活性成分:OXYTOCIN; 剂型/给药途径:INJECTABLE;INJECTION; 规格:100USP UNITS/10ML (10USP UNITS/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
018248 002 NDA OXYTOCIN OXYTOCIN INJECTABLE;INJECTION 100USP UNITS/10ML (10USP UNITS/ML) Prescription Yes Yes AP Approved Prior to Jan 1, 1982 FRESENIUS KABI USA
018243 002 NDA OXYTOCIN OXYTOCIN INJECTABLE;INJECTION 100USP UNITS/10ML (10USP UNITS/ML) Prescription Yes Yes AP 2007/01/10 HIKMA
018261 002 NDA PITOCIN OXYTOCIN INJECTABLE;INJECTION 100USP UNITS/10ML (10USP UNITS/ML) Prescription Yes No AP 2007/07/27 PH HEALTH
091676 002 ANDA OXYTOCIN OXYTOCIN INJECTABLE;INJECTION 100USP UNITS/10ML (10USP UNITS/ML) Prescription No No AP 2018/07/13 SAGENT PHARMS INC
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
参考引用2
©2006-2025 DrugFuture->U.S. FDA Drugs Database