药品注册申请号：021086
申请类型：NDA (新药申请)
申请人：CHEPLAPHARM
申请人全名：CHEPLAPHARM REGISTRATION GMBH
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 ZYPREXA ZYDIS OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 5MG Yes Yes AB 2000/04/06 2000/04/06 Prescription
002 ZYPREXA ZYDIS OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 10MG Yes No AB 2000/04/06 Prescription
003 ZYPREXA ZYDIS OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 15MG Yes No AB 2000/04/06 Prescription
004 ZYPREXA ZYDIS OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 20MG Yes No AB 2000/04/06 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
2000/04/06 ORIG-1（原始申请） Approval Type 3 - New Dosage Form 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
2025/01/22 SUPPL-50（补充） Approval Labeling-Package Insert STANDARD
2020/04/23 SUPPL-48（补充） Approval Labeling-Package Insert STANDARD
2020/04/21 SUPPL-49（补充） Approval Labeling-Package Insert 901 REQUIRED
2019/10/22 SUPPL-47（补充） Approval Labeling-Package Insert STANDARD
2018/03/27 SUPPL-46（补充） Approval Labeling-Package Insert STANDARD
2017/02/23 SUPPL-45（补充） Approval Labeling-Package Insert 901 REQUIRED
2017/02/23 SUPPL-44（补充） Approval Labeling-Package Insert STANDARD
2016/10/06 SUPPL-43（补充） Approval Labeling-Medication Guide,Labeling-Package Insert 901 REQUIRED
2015/07/23 SUPPL-42（补充） Approval Labeling-Package Insert STANDARD
2014/12/19 SUPPL-40（补充） Approval Labeling-Package Insert STANDARD
2013/07/26 SUPPL-41（补充） Approval Efficacy-Pediatric STANDARD
2011/06/21 SUPPL-39（补充） Approval REMS-Modified N/A
2011/06/21 SUPPL-38（补充） Approval REMS-Modified N/A
2010/12/01 SUPPL-36（补充） Approval Labeling 901 REQUIRED
2010/05/27 SUPPL-34（补充） Approval Labeling UNKNOWN
2010/05/27 SUPPL-32（补充） Approval Labeling-Package Insert UNKNOWN
2010/01/27 SUPPL-31（补充） Approval Labeling-Package Insert UNKNOWN
2009/08/31 SUPPL-30（补充） Approval Labeling-Medication Guide UNKNOWN
2009/03/19 SUPPL-21（补充） Approval Efficacy-Labeling Change With Clinical Data,REMS-Proposal PRIORITY
2008/08/14 SUPPL-28（补充） Approval Labeling STANDARD
2007/07/06 SUPPL-23（补充） Approval Labeling STANDARD
2007/07/06 SUPPL-22（补充） Approval Labeling STANDARD
2006/11/29 SUPPL-20（补充） Approval Labeling STANDARD
2006/08/25 SUPPL-11（补充） Approval Labeling STANDARD
2006/02/23 SUPPL-16（补充） Approval Labeling STANDARD
2006/02/16 SUPPL-13（补充） Approval Labeling STANDARD
2006/02/16 SUPPL-9（补充） Approval Labeling STANDARD
2005/09/13 SUPPL-15（补充） Approval Labeling STANDARD
2001/10/24 SUPPL-3（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
001 5229382 2011/04/23 U-324 PDF格式**本条是由Drugfuture回溯的历史信息**
5229382*PED 2011/10/23 PDF格式**本条是由Drugfuture回溯的历史信息**
6960577 2017/11/01 U-964 PDF格式**本条是由Drugfuture回溯的历史信息**
002 5229382 2011/04/23 U-324 PDF格式**本条是由Drugfuture回溯的历史信息**
5229382*PED 2011/10/23 PDF格式**本条是由Drugfuture回溯的历史信息**
6960577 2017/11/01 U-964 PDF格式**本条是由Drugfuture回溯的历史信息**
003 5229382 2011/04/23 U-324 PDF格式**本条是由Drugfuture回溯的历史信息**
5229382*PED 2011/10/23 PDF格式**本条是由Drugfuture回溯的历史信息**
6960577 2017/11/01 U-964 PDF格式**本条是由Drugfuture回溯的历史信息**
004 5229382 2011/04/23 U-324 PDF格式**本条是由Drugfuture回溯的历史信息**
5229382*PED 2011/10/23 PDF格式**本条是由Drugfuture回溯的历史信息**
6960577 2017/11/01 U-964 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
001 I-400 2006/07/10**本条是由Drugfuture回溯的历史信息**
I-417 2007/01/14**本条是由Drugfuture回溯的历史信息**
NPP 2016/07/26**本条是由Drugfuture回溯的历史信息**
PED 2007/01/10**本条是由Drugfuture回溯的历史信息**
PED 2007/07/14**本条是由Drugfuture回溯的历史信息**
002 I-400 2006/07/10**本条是由Drugfuture回溯的历史信息**
I-417 2007/01/14**本条是由Drugfuture回溯的历史信息**
NPP 2016/07/26**本条是由Drugfuture回溯的历史信息**
PED 2007/01/10**本条是由Drugfuture回溯的历史信息**
PED 2007/07/14**本条是由Drugfuture回溯的历史信息**
003 I-400 2006/07/10**本条是由Drugfuture回溯的历史信息**
I-417 2007/01/14**本条是由Drugfuture回溯的历史信息**
NPP 2016/07/26**本条是由Drugfuture回溯的历史信息**
PED 2007/01/10**本条是由Drugfuture回溯的历史信息**
PED 2007/07/14**本条是由Drugfuture回溯的历史信息**
004 I-400 2006/07/10**本条是由Drugfuture回溯的历史信息**
I-417 2007/01/14**本条是由Drugfuture回溯的历史信息**
NPP 2016/07/26**本条是由Drugfuture回溯的历史信息**
PED 2007/01/10**本条是由Drugfuture回溯的历史信息**
PED 2007/07/14**本条是由Drugfuture回溯的历史信息**
与本品治疗等效的药品
>>>活性成分:OLANZAPINE; 剂型/给药途径:TABLET, ORALLY DISINTEGRATING;ORAL; 规格:5MG; 治疗等效代码:AB<<<
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
021086 001 NDA ZYPREXA ZYDIS OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 5MG Prescription Yes Yes AB 2000/04/06 CHEPLAPHARM
076534 001 ANDA OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 5MG Prescription No No AB 2011/10/24 DR REDDYS LABS LTD
078109 001 ANDA OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 5MG Prescription No No AB 2011/10/24 STRIDES PHARMA INTL
091265 001 ANDA OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 5MG Prescription No No AB 2011/10/24 APOTEX INC
091415 001 ANDA OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 5MG Prescription No No AB 2011/10/25 TORRENT
077243 001 ANDA OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 5MG Prescription No No AB 2012/01/30 BARR LABS INC
090881 001 ANDA OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 5MG Discontinued No No AB 2012/02/28 SUN PHARM INDS
200221 001 ANDA OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 5MG Prescription No No AB 2012/09/12 JUBILANT GENERICS
202285 001 ANDA OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 5MG Prescription No No AB 2014/05/12 PHARMOBEDIENT
203708 001 ANDA OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 5MG Prescription No No AB 2014/05/15 AUROBINDO PHARMA LTD
203044 001 ANDA OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 5MG Prescription No No AB 2015/02/20 MACLEODS PHARMS LTD
202937 001 ANDA OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 5MG Prescription No No AB 2015/03/02 ORBION PHARMS
203456 001 ANDA OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 5MG Prescription No No AB 2016/03/16 CHARTWELL MOLECULAR
208146 001 ANDA OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 5MG Prescription No No AB 2018/07/02 HEC PHARM
206892 001 ANDA OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 5MG Prescription No No AB 2020/12/31 HISUN PHARM HANGZHOU
202889 001 ANDA OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 5MG Discontinued No No AB 2023/03/09 ZYDUS PHARMS
>>>活性成分:OLANZAPINE; 剂型/给药途径:TABLET, ORALLY DISINTEGRATING;ORAL; 规格:10MG; 治疗等效代码:AB<<<
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
021086 002 NDA ZYPREXA ZYDIS OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 10MG Prescription Yes No AB 2000/04/06 CHEPLAPHARM
076534 002 ANDA OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 10MG Prescription No No AB 2011/10/24 DR REDDYS LABS LTD
078109 002 ANDA OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 10MG Prescription No No AB 2011/10/24 STRIDES PHARMA INTL
091265 002 ANDA OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 10MG Prescription No No AB 2011/10/24 APOTEX INC
091415 002 ANDA OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 10MG Prescription No No AB 2011/10/25 TORRENT
077243 002 ANDA OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 10MG Prescription No No AB 2012/01/30 BARR LABS INC
090881 002 ANDA OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 10MG Discontinued No No AB 2012/02/28 SUN PHARM INDS
200221 002 ANDA OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 10MG Prescription No No AB 2012/09/12 JUBILANT GENERICS
202285 002 ANDA OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 10MG Prescription No No AB 2014/05/12 PHARMOBEDIENT
203708 002 ANDA OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 10MG Prescription No No AB 2014/05/15 AUROBINDO PHARMA LTD
203044 002 ANDA OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 10MG Prescription No No AB 2015/02/20 MACLEODS PHARMS LTD
202937 002 ANDA OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 10MG Prescription No No AB 2015/03/02 ORBION PHARMS
203456 002 ANDA OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 10MG Prescription No No AB 2016/03/16 CHARTWELL MOLECULAR
208146 002 ANDA OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 10MG Prescription No No AB 2018/07/02 HEC PHARM
206892 002 ANDA OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 10MG Prescription No No AB 2020/12/31 HISUN PHARM HANGZHOU
202889 002 ANDA OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 10MG Discontinued No No AB 2023/03/09 ZYDUS PHARMS
>>>活性成分:OLANZAPINE; 剂型/给药途径:TABLET, ORALLY DISINTEGRATING;ORAL; 规格:15MG; 治疗等效代码:AB<<<
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
021086 003 NDA ZYPREXA ZYDIS OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 15MG Prescription Yes No AB 2000/04/06 CHEPLAPHARM
076534 003 ANDA OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 15MG Prescription No No AB 2011/10/24 DR REDDYS LABS LTD
078109 003 ANDA OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 15MG Prescription No No AB 2011/10/24 STRIDES PHARMA INTL
091265 003 ANDA OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 15MG Prescription No No AB 2011/10/24 APOTEX INC
091415 003 ANDA OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 15MG Prescription No No AB 2011/10/25 TORRENT
077243 003 ANDA OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 15MG Prescription No No AB 2012/01/30 BARR LABS INC
090881 003 ANDA OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 15MG Discontinued No No AB 2012/02/28 SUN PHARM INDS
200221 003 ANDA OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 15MG Prescription No No AB 2012/09/12 JUBILANT GENERICS
202285 003 ANDA OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 15MG Prescription No No AB 2014/05/12 PHARMOBEDIENT
203708 003 ANDA OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 15MG Prescription No No AB 2014/05/15 AUROBINDO PHARMA LTD
203044 003 ANDA OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 15MG Prescription No No AB 2015/02/20 MACLEODS PHARMS LTD
202937 003 ANDA OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 15MG Prescription No No AB 2015/03/02 ORBION PHARMS
203456 003 ANDA OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 15MG Prescription No No AB 2016/03/16 CHARTWELL MOLECULAR
208146 003 ANDA OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 15MG Prescription No No AB 2018/07/02 HEC PHARM
206892 003 ANDA OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 15MG Prescription No No AB 2020/12/31 HISUN PHARM HANGZHOU
202889 003 ANDA OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 15MG Discontinued No No AB 2023/03/09 ZYDUS PHARMS
>>>活性成分:OLANZAPINE; 剂型/给药途径:TABLET, ORALLY DISINTEGRATING;ORAL; 规格:20MG; 治疗等效代码:AB<<<
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
021086 004 NDA ZYPREXA ZYDIS OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 20MG Prescription Yes No AB 2000/04/06 CHEPLAPHARM
076534 004 ANDA OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 20MG Prescription No No AB 2011/10/24 DR REDDYS LABS LTD
078109 004 ANDA OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 20MG Prescription No No AB 2011/10/24 STRIDES PHARMA INTL
091265 004 ANDA OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 20MG Prescription No No AB 2011/10/24 APOTEX INC
091415 004 ANDA OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 20MG Prescription No No AB 2011/10/25 TORRENT
077243 004 ANDA OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 20MG Prescription No No AB 2012/01/30 BARR LABS INC
090881 004 ANDA OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 20MG Discontinued No No AB 2012/02/28 SUN PHARM INDS
200221 004 ANDA OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 20MG Prescription No No AB 2012/09/12 JUBILANT GENERICS
202285 004 ANDA OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 20MG Prescription No No AB 2014/05/12 PHARMOBEDIENT
203708 004 ANDA OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 20MG Prescription No No AB 2014/05/15 AUROBINDO PHARMA LTD
203044 004 ANDA OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 20MG Prescription No No AB 2015/02/20 MACLEODS PHARMS LTD
202937 004 ANDA OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 20MG Prescription No No AB 2015/03/02 ORBION PHARMS
203456 004 ANDA OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 20MG Prescription No No AB 2016/03/16 CHARTWELL MOLECULAR
208146 004 ANDA OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 20MG Prescription No No AB 2018/07/02 HEC PHARM
206892 004 ANDA OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 20MG Prescription No No AB 2020/12/31 HISUN PHARM HANGZHOU
202889 004 ANDA OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 20MG Discontinued No No AB 2023/03/09 ZYDUS PHARMS
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