OCTREOTIDE ACETATE-美国FDA药品数据库-药物在线

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	OCTREOTIDE ACETATE	OCTREOTIDE ACETATE	INJECTABLE;INJECTION	EQ 0.2MG BASE/ML	No	No	AP	2013/11/12	2013/11/12	Prescription
002	OCTREOTIDE ACETATE	OCTREOTIDE ACETATE	INJECTABLE;INJECTION	EQ 1MG BASE/ML	No	No	AP	2013/11/12	2013/11/12	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
2019/08/27	SUPPL-5（补充）	Approval	Labeling	STANDARD
2017/07/10	SUPPL-3（补充）	Approval	Labeling	STANDARD
2013/11/12	ORIG-1（原始申请）	Approval

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:OCTREOTIDE ACETATE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 0.2MG 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	RLD	RS	TE Code	产品号批准日期	申请人
076330	001	ANDA	OCTREOTIDE ACETATE	OCTREOTIDE ACETATE	INJECTABLE;INJECTION	EQ 0.2MG BASE/ML	Prescription	No	Yes	AP	2005/04/08	WEST-WARD PHARMS INT
075959	001	ANDA	OCTREOTIDE ACETATE	OCTREOTIDE ACETATE	INJECTABLE;INJECTION	EQ 0.2MG BASE/ML	Prescription	No	No	AP	2005/11/21	MEITHEAL
077450	001	ANDA	OCTREOTIDE ACETATE	OCTREOTIDE ACETATE	INJECTABLE;INJECTION	EQ 0.2MG BASE/ML	Prescription	No	No	AP	2006/02/10	FRESENIUS KABI USA
091041	001	ANDA	OCTREOTIDE ACETATE	OCTREOTIDE ACETATE	INJECTABLE;INJECTION	EQ 0.2MG BASE/ML	Prescription	No	No	AP	2013/11/12	SAGENT PHARMS INC
203765	001	ANDA	OCTREOTIDE ACETATE	OCTREOTIDE ACETATE	INJECTABLE;INJECTION	EQ 0.2MG BASE/ML	Prescription	No	No	AP	2018/09/07	HERITAGE
216807	001	ANDA	OCTREOTIDE ACETATE	OCTREOTIDE ACETATE	INJECTABLE;INJECTION	EQ 0.2MG BASE/ML	Prescription	No	No	AP	2023/06/13	GLAND PHARMA LTD

活性成分:OCTREOTIDE ACETATE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 1MG 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	RLD	RS	TE Code	产品号批准日期	申请人
076330	002	ANDA	OCTREOTIDE ACETATE	OCTREOTIDE ACETATE	INJECTABLE;INJECTION	EQ 1MG BASE/ML	Prescription	No	Yes	AP	2005/04/08	WEST-WARD PHARMS INT
075959	002	ANDA	OCTREOTIDE ACETATE	OCTREOTIDE ACETATE	INJECTABLE;INJECTION	EQ 1MG BASE/ML	Prescription	No	No	AP	2005/11/21	MEITHEAL
077450	002	ANDA	OCTREOTIDE ACETATE	OCTREOTIDE ACETATE	INJECTABLE;INJECTION	EQ 1MG BASE/ML	Prescription	No	No	AP	2006/02/10	FRESENIUS KABI USA
091041	002	ANDA	OCTREOTIDE ACETATE	OCTREOTIDE ACETATE	INJECTABLE;INJECTION	EQ 1MG BASE/ML	Prescription	No	No	AP	2013/11/12	SAGENT PHARMS INC
203765	002	ANDA	OCTREOTIDE ACETATE	OCTREOTIDE ACETATE	INJECTABLE;INJECTION	EQ 1MG BASE/ML	Prescription	No	No	AP	2018/09/07	HERITAGE
216807	002	ANDA	OCTREOTIDE ACETATE	OCTREOTIDE ACETATE	INJECTABLE;INJECTION	EQ 1MG BASE/ML	Prescription	No	No	AP	2023/06/13	GLAND PHARMA LTD