药品注册申请号：079198
申请类型：ANDA (仿制药申请)
申请人：MYLAN INSTITUTIONAL
申请人全名：MYLAN INSTITUTIONAL 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 OCTREOTIDE ACETATE (PRESERVATIVE FREE) OCTREOTIDE ACETATE INJECTABLE;INJECTION EQ 0.05MG BASE/ML No No AP 2011/02/10 2011/02/10 Prescription
002 OCTREOTIDE ACETATE (PRESERVATIVE FREE) OCTREOTIDE ACETATE INJECTABLE;INJECTION EQ 0.1MG BASE/ML No No AP 2011/02/10 Prescription
003 OCTREOTIDE ACETATE (PRESERVATIVE FREE) OCTREOTIDE ACETATE INJECTABLE;INJECTION EQ 0.5MG BASE/ML No No AP 2011/02/10 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；罕用药状态通知信、审评文件、说明书、包装标签备注
2023/02/21 SUPPL-13（补充） Approval Labeling STANDARD
2023/02/21 SUPPL-11（补充） Approval Labeling STANDARD
2023/02/21 SUPPL-10（补充） Approval Labeling STANDARD
2019/09/05 SUPPL-7（补充） Approval Labeling STANDARD
2017/07/07 SUPPL-6（补充） Approval Labeling STANDARD
2017/07/07 SUPPL-5（补充） Approval Labeling STANDARD
2013/05/23 SUPPL-3（补充） Approval Labeling STANDARD
2011/12/02 SUPPL-2（补充） Approval Labeling
2011/07/14 SUPPL-1（补充） Approval Labeling
2011/02/10 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 0.05MG 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
019667 001 NDA SANDOSTATIN OCTREOTIDE ACETATE INJECTABLE;INJECTION EQ 0.05MG BASE/ML Prescription Yes Yes AP 1988/10/21 NOVARTIS
076313 001 ANDA OCTREOTIDE ACETATE (PRESERVATIVE FREE) OCTREOTIDE ACETATE INJECTABLE;INJECTION EQ 0.05MG BASE/ML Prescription No Yes AP 2005/03/28 WEST-WARD PHARMS INT
075957 001 ANDA OCTREOTIDE ACETATE OCTREOTIDE ACETATE INJECTABLE;INJECTION EQ 0.05MG BASE/ML Prescription No No AP 2005/10/03 MEITHEAL
077457 001 ANDA OCTREOTIDE ACETATE (PRESERVATIVE FREE) OCTREOTIDE ACETATE INJECTABLE;INJECTION EQ 0.05MG BASE/ML Prescription No No AP 2006/02/10 FRESENIUS KABI USA
079198 001 ANDA OCTREOTIDE ACETATE (PRESERVATIVE FREE) OCTREOTIDE ACETATE INJECTABLE;INJECTION EQ 0.05MG BASE/ML Prescription No No AP 2011/02/10 MYLAN INSTITUTIONAL
090834 001 ANDA OCTREOTIDE ACETATE (PRESERVATIVE FREE) OCTREOTIDE ACETATE INJECTABLE;INJECTION EQ 0.05MG BASE/ML Prescription No No AP 2013/11/12 SAGENT PHARMS INC
204669 001 ANDA OCTREOTIDE ACETATE OCTREOTIDE ACETATE INJECTABLE;INJECTION EQ 0.05MG BASE/ML Prescription No No AP 2018/12/27 HERITAGE
活性成分:OCTREOTIDE ACETATE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 0.1MG 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RLDRSTE Code产品号批准日期申请人
019667 002 NDA SANDOSTATIN OCTREOTIDE ACETATE INJECTABLE;INJECTION EQ 0.1MG BASE/ML Prescription Yes Yes AP 1988/10/21 NOVARTIS
076313 003 ANDA OCTREOTIDE ACETATE (PRESERVATIVE FREE) OCTREOTIDE ACETATE INJECTABLE;INJECTION EQ 0.1MG BASE/ML Prescription No Yes AP 2005/03/28 WEST-WARD PHARMS INT
075957 002 ANDA OCTREOTIDE ACETATE OCTREOTIDE ACETATE INJECTABLE;INJECTION EQ 0.1MG BASE/ML Prescription No No AP 2005/10/03 MEITHEAL
077457 002 ANDA OCTREOTIDE ACETATE (PRESERVATIVE FREE) OCTREOTIDE ACETATE INJECTABLE;INJECTION EQ 0.1MG BASE/ML Prescription No No AP 2006/02/10 FRESENIUS KABI USA
079198 002 ANDA OCTREOTIDE ACETATE (PRESERVATIVE FREE) OCTREOTIDE ACETATE INJECTABLE;INJECTION EQ 0.1MG BASE/ML Prescription No No AP 2011/02/10 MYLAN INSTITUTIONAL
090834 002 ANDA OCTREOTIDE ACETATE (PRESERVATIVE FREE) OCTREOTIDE ACETATE INJECTABLE;INJECTION EQ 0.1MG BASE/ML Prescription No No AP 2013/11/12 SAGENT PHARMS INC
204669 002 ANDA OCTREOTIDE ACETATE OCTREOTIDE ACETATE INJECTABLE;INJECTION EQ 0.1MG BASE/ML Prescription No No AP 2018/12/27 HERITAGE
216839 002 ANDA OCTREOTIDE ACETATE OCTREOTIDE ACETATE INJECTABLE;INJECTION EQ 0.1MG BASE/ML Prescription No No AP 2023/06/22 GLAND PHARMA LTD
217860 001 ANDA OCTREOTIDE ACETATE OCTREOTIDE ACETATE INJECTABLE;INJECTION EQ 0.1MG BASE/ML Discontinued No No AP 2024/05/02 SHUANGCHENG
活性成分:OCTREOTIDE ACETATE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 0.5MG 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
019667 003 NDA SANDOSTATIN OCTREOTIDE ACETATE INJECTABLE;INJECTION EQ 0.5MG BASE/ML Prescription Yes Yes AP 1988/10/21 NOVARTIS
076313 002 ANDA OCTREOTIDE ACETATE (PRESERVATIVE FREE) OCTREOTIDE ACETATE INJECTABLE;INJECTION EQ 0.5MG BASE/ML Prescription No Yes AP 2005/03/28 WEST-WARD PHARMS INT
075957 003 ANDA OCTREOTIDE ACETATE OCTREOTIDE ACETATE INJECTABLE;INJECTION EQ 0.5MG BASE/ML Prescription No No AP 2005/10/03 MEITHEAL
077457 003 ANDA OCTREOTIDE ACETATE (PRESERVATIVE FREE) OCTREOTIDE ACETATE INJECTABLE;INJECTION EQ 0.5MG BASE/ML Prescription No No AP 2006/02/10 FRESENIUS KABI USA
079198 003 ANDA OCTREOTIDE ACETATE (PRESERVATIVE FREE) OCTREOTIDE ACETATE INJECTABLE;INJECTION EQ 0.5MG BASE/ML Prescription No No AP 2011/02/10 MYLAN INSTITUTIONAL
090834 003 ANDA OCTREOTIDE ACETATE (PRESERVATIVE FREE) OCTREOTIDE ACETATE INJECTABLE;INJECTION EQ 0.5MG BASE/ML Prescription No No AP 2013/11/12 SAGENT PHARMS INC
204669 003 ANDA OCTREOTIDE ACETATE OCTREOTIDE ACETATE INJECTABLE;INJECTION EQ 0.5MG BASE/ML Prescription No No AP 2018/12/27 HERITAGE
216839 001 ANDA OCTREOTIDE ACETATE OCTREOTIDE ACETATE INJECTABLE;INJECTION EQ 0.5MG BASE/ML Prescription No No AP 2023/06/22 GLAND PHARMA LTD
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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