药品注册申请号：019667
申请类型：NDA (新药申请)
申请人：NOVARTIS
申请人全名：NOVARTIS PHARMACEUTICALS CORP
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 SANDOSTATIN OCTREOTIDE ACETATE INJECTABLE;INJECTION EQ 0.05MG BASE/ML Yes Yes AP 1988/10/21 1988/10/21 Prescription
002 SANDOSTATIN OCTREOTIDE ACETATE INJECTABLE;INJECTION EQ 0.1MG BASE/ML Yes Yes AP 1988/10/21 Prescription
003 SANDOSTATIN OCTREOTIDE ACETATE INJECTABLE;INJECTION EQ 0.5MG BASE/ML Yes Yes AP 1988/10/21 Prescription
004 SANDOSTATIN OCTREOTIDE ACETATE INJECTABLE;INJECTION EQ 0.2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1991/06/12 Discontinued
005 SANDOSTATIN OCTREOTIDE ACETATE INJECTABLE;INJECTION EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1991/06/12 Discontinued
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
2023/11/03 SUPPL-76（补充） Approval Labeling STANDARD
2022/10/04 SUPPL-73（补充） Approval Labeling STANDARD
2021/10/20 SUPPL-71（补充） Approval Labeling STANDARD
2021/05/25 SUPPL-70（补充） Approval Labeling STANDARD
2019/04/11 SUPPL-67（补充） Approval Labeling 901 REQUIRED
2015/02/21 SUPPL-62（补充） Approval Labeling STANDARD
2014/02/04 SUPPL-59（补充） Approval Manufacturing (CMC) PRIORITY
2012/03/23 SUPPL-61（补充） Approval Labeling STANDARD
2010/01/25 SUPPL-58（补充） Approval Labeling STANDARD
2008/08/26 SUPPL-54（补充） Approval Labeling STANDARD
2005/09/02 SUPPL-50（补充） Approval Labeling STANDARD
2003/02/10 SUPPL-42（补充） Approval Manufacturing (CMC) PRIORITY
2003/01/17 SUPPL-44（补充） Approval Manufacturing (CMC) PRIORITY
2002/07/24 SUPPL-32（补充） Approval Labeling STANDARD
2002/07/24 SUPPL-28（补充） Approval Labeling STANDARD
2002/05/28 SUPPL-43（补充） Approval Manufacturing (CMC) PRIORITY
2002/05/13 SUPPL-41（补充） Approval Manufacturing (CMC) PRIORITY
2002/01/03 SUPPL-40（补充） Approval Manufacturing (CMC) PRIORITY
2001/07/02 SUPPL-38（补充） Approval Labeling STANDARD
2001/06/21 SUPPL-39（补充） Approval Manufacturing (CMC) PRIORITY
1999/02/17 SUPPL-36（补充） Approval Manufacturing (CMC) PRIORITY
1999/02/17 SUPPL-35（补充） Approval Manufacturing (CMC) PRIORITY
1998/12/17 SUPPL-33（补充） Approval Manufacturing (CMC) PRIORITY
1998/07/31 SUPPL-34（补充） Approval Manufacturing (CMC) PRIORITY
1997/10/24 SUPPL-31（补充） Approval Manufacturing (CMC) PRIORITY
1997/10/24 SUPPL-30（补充） Approval Manufacturing (CMC) PRIORITY
1997/10/24 SUPPL-29（补充） Approval Manufacturing (CMC) PRIORITY
1997/10/24 SUPPL-27（补充） Approval Manufacturing (CMC) PRIORITY
1996/10/21 SUPPL-26（补充） Approval Manufacturing (CMC) PRIORITY
1996/08/14 SUPPL-25（补充） Approval Manufacturing (CMC) PRIORITY
1996/07/16 SUPPL-24（补充） Approval Manufacturing (CMC) PRIORITY
1996/06/12 SUPPL-23（补充） Approval Manufacturing (CMC) PRIORITY
1996/02/16 SUPPL-22（补充） Approval Manufacturing (CMC) PRIORITY
1995/12/18 SUPPL-20（补充） Approval Manufacturing (CMC) PRIORITY
1995/11/07 SUPPL-11（补充） Approval Manufacturing (CMC) PRIORITY
1995/10/10 SUPPL-12（补充） Approval Manufacturing (CMC) PRIORITY
1995/02/06 SUPPL-19（补充） Approval Manufacturing (CMC) PRIORITY
1994/12/06 SUPPL-21（补充） Approval Manufacturing (CMC) PRIORITY
1994/05/03 SUPPL-17（补充） Approval Efficacy STANDARD
1993/01/12 SUPPL-16（补充） Approval Manufacturing (CMC) PRIORITY
1992/09/30 SUPPL-15（补充） Approval Manufacturing (CMC) PRIORITY
1992/07/31 SUPPL-14（补充） Approval Labeling
1992/02/28 SUPPL-10（补充） Approval Manufacturing (CMC) PRIORITY
1991/10/04 SUPPL-8（补充） Approval Labeling
1991/07/03 SUPPL-7（补充） Approval Labeling
1991/06/12 SUPPL-4（补充） Approval Manufacturing (CMC) PRIORITY
1990/04/16 SUPPL-5（补充） Approval Labeling
1989/06/23 SUPPL-3（补充） Approval Manufacturing (CMC) PRIORITY
1988/10/21 ORIG-1（原始申请） Approval Type 1 - New Molecular Entity PRIORITY
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
001 5753618 2015/05/19 PDF格式**本条是由Drugfuture回溯的历史信息**
5753618*PED 2015/11/19 PDF格式**本条是由Drugfuture回溯的历史信息**
002 5753618 2015/05/19 PDF格式**本条是由Drugfuture回溯的历史信息**
5753618*PED 2015/11/19 PDF格式**本条是由Drugfuture回溯的历史信息**
003 5753618 2015/05/19 PDF格式**本条是由Drugfuture回溯的历史信息**
5753618*PED 2015/11/19 PDF格式**本条是由Drugfuture回溯的历史信息**
004 5753618 2015/05/19 PDF格式**本条是由Drugfuture回溯的历史信息**
5753618*PED 2015/11/19 PDF格式**本条是由Drugfuture回溯的历史信息**
005 5753618 2015/05/19 PDF格式**本条是由Drugfuture回溯的历史信息**
5753618*PED 2015/11/19 PDF格式**本条是由Drugfuture回溯的历史信息**
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 PHARMS
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 PHARMS
216839 002 ANDA OCTREOTIDE ACETATE OCTREOTIDE ACETATE INJECTABLE;INJECTION EQ 0.1MG BASE/ML Prescription No No AP 2023/06/22 GLAND PHARMA LTD
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 PHARMS
216839 001 ANDA OCTREOTIDE ACETATE OCTREOTIDE ACETATE INJECTABLE;INJECTION EQ 0.5MG BASE/ML Prescription No No AP 2023/06/22 GLAND PHARMA LTD
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药品NDC数据与药品包装、标签说明书
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