药品注册申请号：018261
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 PITOCIN OXYTOCIN INJECTABLE;INJECTION 10USP UNITS/ML (10USP UNITS/ML) Yes Yes AP 1980/11/19 Approved Prior to Jan 1, 1982 Prescription
002 PITOCIN OXYTOCIN INJECTABLE;INJECTION 100USP UNITS/10ML (10USP UNITS/ML) Yes No AP 2007/07/27 Prescription
003 PITOCIN OXYTOCIN INJECTABLE;INJECTION 500USP UNITS/50ML (10USP UNITS/ML) Yes No None 2012/09/05 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
1980/11/19 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
2021/05/11 SUPPL-41（补充） Approval Labeling-Container/Carton Labels,Labeling-Package Insert STANDARD
2016/08/15 SUPPL-33（补充） Approval Manufacturing (CMC)-Manufacturing Process N/A
2014/10/02 SUPPL-31（补充） Approval Labeling-Package Insert STANDARD
2014/06/18 SUPPL-32（补充） Approval Manufacturing (CMC) STANDARD
2007/07/27 SUPPL-28（补充） Approval Labeling-Container/Carton Labels,Labeling-Package Insert N/A
2003/03/24 SUPPL-23（补充） Approval Labeling STANDARD
2002/01/10 SUPPL-21（补充） Approval Labeling STANDARD
2001/09/24 SUPPL-22（补充） Approval Manufacturing (CMC)-Control STANDARD
2001/03/08 SUPPL-20（补充） Approval Labeling STANDARD
2001/03/08 SUPPL-19（补充） Approval Manufacturing (CMC)-Expiration Date STANDARD
2001/03/08 SUPPL-18（补充） Approval Manufacturing (CMC)-Control STANDARD
2000/10/25 SUPPL-17（补充） Approval Manufacturing (CMC)-Control STANDARD
2000/03/23 SUPPL-16（补充） Approval Manufacturing (CMC)-Packaging STANDARD
2000/03/01 SUPPL-15（补充） Approval Manufacturing (CMC)-Expiration Date STANDARD
1999/11/10 SUPPL-14（补充） Approval Manufacturing (CMC)-Control STANDARD
1999/02/22 SUPPL-13（补充） Approval Labeling STANDARD
1997/07/29 SUPPL-11（补充） Approval Labeling STANDARD
1997/07/10 SUPPL-12（补充） Approval Manufacturing (CMC)-Control STANDARD
1996/02/22 SUPPL-9（补充） Approval Labeling STANDARD
1994/08/23 SUPPL-7（补充） Approval Labeling STANDARD
1994/08/09 SUPPL-6（补充） Approval Labeling
1994/05/27 SUPPL-8（补充） Approval Manufacturing (CMC)-Control STANDARD
1990/07/03 SUPPL-5（补充） Approval Labeling
1988/02/16 SUPPL-4（补充） Approval Labeling
1987/01/29 SUPPL-3（补充） Approval Manufacturing (CMC)-Control STANDARD
1986/09/19 SUPPL-2（补充） Approval Labeling
1984/01/27 SUPPL-1（补充） Approval Manufacturing (CMC)-Control 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
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