药品注册申请号：090798
申请类型：ANDA (仿制药申请)
申请人：APOTEX INC
申请人全名：APOTEX INC
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 OLANZAPINE OLANZAPINE TABLET;ORAL 2.5MG No No AB 2012/04/23 2012/04/23 Prescription
002 OLANZAPINE OLANZAPINE TABLET;ORAL 5MG No No AB 2012/04/23 Prescription
003 OLANZAPINE OLANZAPINE TABLET;ORAL 7.5MG No No AB 2012/04/23 Prescription
004 OLANZAPINE OLANZAPINE TABLET;ORAL 10MG No No AB 2012/04/23 Prescription
005 OLANZAPINE OLANZAPINE TABLET;ORAL 15MG No No AB 2012/04/23 Prescription
006 OLANZAPINE OLANZAPINE TABLET;ORAL 20MG No No AB 2012/04/23 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
2023/06/13 SUPPL-18（补充） Approval Labeling STANDARD
2023/06/13 SUPPL-14（补充） Approval Labeling STANDARD
2023/06/13 SUPPL-12（补充） Approval Labeling STANDARD
2023/06/13 SUPPL-10（补充） Approval Labeling STANDARD
2023/06/13 SUPPL-6（补充） Approval Labeling STANDARD
2023/06/13 SUPPL-4（补充） Approval Labeling STANDARD
2012/04/23 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:OLANZAPINE 剂型/给药途径:TABLET;ORAL 规格:2.5MG 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
020592 001 NDA ZYPREXA OLANZAPINE TABLET;ORAL 2.5MG Prescription Yes No AB 1996/09/30 CHEPLAPHARM
076255 001 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 2.5MG Prescription No No AB 2012/04/23 DR REDDYS LABS LTD
090798 001 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 2.5MG Prescription No No AB 2012/04/23 APOTEX INC
091038 001 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 2.5MG Discontinued No No AB 2012/04/23 SUN PHARM INDS
202050 001 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 2.5MG Prescription No No AB 2012/04/23 AUROBINDO PHARMA LTD
202287 001 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 2.5MG Prescription No No AB 2012/04/23 ORBION PHARMS
202862 001 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 2.5MG Prescription No No AB 2014/08/15 MACLEODS PHARMS LTD
202295 001 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 2.5MG Prescription No No AB 2015/10/20 ALKEM LABS LTD
204319 001 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 2.5MG Prescription No No AB 2016/01/27 QILU
203333 001 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 2.5MG Prescription No No AB 2016/03/15 CHARTWELL MOLECULAR
090459 001 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 2.5MG Prescription No No AB 2018/07/16 ZYDUS PHARMS
206155 001 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 2.5MG Discontinued No No AB 2020/07/31 INDOCO
210022 001 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 2.5MG Prescription No No AB 2023/02/24 CADILA PHARMS LTD
活性成分:OLANZAPINE 剂型/给药途径:TABLET;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
020592 002 NDA ZYPREXA OLANZAPINE TABLET;ORAL 5MG Prescription Yes Yes AB 1996/09/30 CHEPLAPHARM
076255 002 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 5MG Prescription No No AB 2012/04/23 DR REDDYS LABS LTD
090798 002 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 5MG Prescription No No AB 2012/04/23 APOTEX INC
091038 002 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 5MG Discontinued No No AB 2012/04/23 SUN PHARM INDS
202050 002 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 5MG Prescription No No AB 2012/04/23 AUROBINDO PHARMA LTD
202287 002 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 5MG Prescription No No AB 2012/04/23 ORBION PHARMS
202862 002 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 5MG Prescription No No AB 2014/08/15 MACLEODS PHARMS LTD
202295 002 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 5MG Prescription No No AB 2015/10/20 ALKEM LABS LTD
204319 002 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 5MG Prescription No No AB 2016/01/27 QILU
203333 002 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 5MG Prescription No No AB 2016/03/15 CHARTWELL MOLECULAR
090459 002 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 5MG Prescription No No AB 2018/07/16 ZYDUS PHARMS
206155 002 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 5MG Discontinued No No AB 2020/07/31 INDOCO
210022 002 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 5MG Prescription No No AB 2023/02/24 CADILA PHARMS LTD
活性成分:OLANZAPINE 剂型/给药途径:TABLET;ORAL 规格:7.5MG 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
020592 003 NDA ZYPREXA OLANZAPINE TABLET;ORAL 7.5MG Prescription Yes No AB 1996/09/30 CHEPLAPHARM
076255 003 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 7.5MG Prescription No No AB 2012/04/23 DR REDDYS LABS LTD
090798 003 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 7.5MG Prescription No No AB 2012/04/23 APOTEX INC
091038 003 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 7.5MG Discontinued No No AB 2012/04/23 SUN PHARM INDS
202050 003 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 7.5MG Prescription No No AB 2012/04/23 AUROBINDO PHARMA LTD
202287 003 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 7.5MG Prescription No No AB 2012/04/23 ORBION PHARMS
202862 003 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 7.5MG Prescription No No AB 2014/08/15 MACLEODS PHARMS LTD
202295 003 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 7.5MG Prescription No No AB 2015/10/20 ALKEM LABS LTD
204319 003 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 7.5MG Prescription No No AB 2016/01/27 QILU
203333 003 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 7.5MG Prescription No No AB 2016/03/15 CHARTWELL MOLECULAR
090459 003 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 7.5MG Prescription No No AB 2018/07/16 ZYDUS PHARMS
206155 003 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 7.5MG Discontinued No No AB 2020/07/31 INDOCO
210022 003 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 7.5MG Prescription No No AB 2023/02/24 CADILA PHARMS LTD
活性成分:OLANZAPINE 剂型/给药途径:TABLET;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
020592 004 NDA ZYPREXA OLANZAPINE TABLET;ORAL 10MG Prescription Yes No AB 1996/09/30 CHEPLAPHARM
076255 004 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 10MG Prescription No No AB 2012/04/23 DR REDDYS LABS LTD
090798 004 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 10MG Prescription No No AB 2012/04/23 APOTEX INC
091038 004 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 10MG Discontinued No No AB 2012/04/23 SUN PHARM INDS
202050 004 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 10MG Prescription No No AB 2012/04/23 AUROBINDO PHARMA LTD
202287 004 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 10MG Prescription No No AB 2012/04/23 ORBION PHARMS
202862 004 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 10MG Prescription No No AB 2014/08/15 MACLEODS PHARMS LTD
202295 004 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 10MG Prescription No No AB 2015/10/20 ALKEM LABS LTD
204319 004 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 10MG Prescription No No AB 2016/01/27 QILU
203333 004 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 10MG Prescription No No AB 2016/03/15 CHARTWELL MOLECULAR
090459 004 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 10MG Prescription No No AB 2018/07/16 ZYDUS PHARMS
206155 004 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 10MG Discontinued No No AB 2020/07/31 INDOCO
210022 004 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 10MG Prescription No No AB 2023/02/24 CADILA PHARMS LTD
活性成分:OLANZAPINE 剂型/给药途径:TABLET;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
020592 005 NDA ZYPREXA OLANZAPINE TABLET;ORAL 15MG Prescription Yes No AB 1997/09/09 CHEPLAPHARM
076133 001 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 15MG Prescription No No AB 2012/04/23 DR REDDYS LABS LTD
090798 005 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 15MG Prescription No No AB 2012/04/23 APOTEX INC
091038 005 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 15MG Discontinued No No AB 2012/04/23 SUN PHARM INDS
202050 005 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 15MG Prescription No No AB 2012/04/23 AUROBINDO PHARMA LTD
202287 005 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 15MG Prescription No No AB 2012/04/23 ORBION PHARMS
202862 005 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 15MG Prescription No No AB 2014/08/15 MACLEODS PHARMS LTD
202295 005 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 15MG Prescription No No AB 2015/10/20 ALKEM LABS LTD
204319 005 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 15MG Prescription No No AB 2016/01/27 QILU
203333 005 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 15MG Prescription No No AB 2016/03/15 CHARTWELL MOLECULAR
090459 005 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 15MG Prescription No No AB 2018/07/16 ZYDUS PHARMS
206155 005 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 15MG Discontinued No No AB 2020/07/31 INDOCO
210022 005 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 15MG Prescription No No AB 2023/02/24 CADILA PHARMS LTD
活性成分:OLANZAPINE 剂型/给药途径:TABLET;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
020592 006 NDA ZYPREXA OLANZAPINE TABLET;ORAL 20MG Prescription Yes No AB 1997/09/09 CHEPLAPHARM
076133 002 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 20MG Prescription No No AB 2011/10/24 DR REDDYS LABS LTD
090798 006 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 20MG Prescription No No AB 2012/04/23 APOTEX INC
091038 006 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 20MG Discontinued No No AB 2012/04/23 SUN PHARM INDS
202050 006 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 20MG Prescription No No AB 2012/04/23 AUROBINDO PHARMA LTD
202287 006 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 20MG Prescription No No AB 2012/04/23 ORBION PHARMS
202862 006 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 20MG Prescription No No AB 2014/08/15 MACLEODS PHARMS LTD
202295 006 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 20MG Prescription No No AB 2015/10/20 ALKEM LABS LTD
204319 006 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 20MG Prescription No No AB 2016/01/27 QILU
203333 006 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 20MG Prescription No No AB 2016/03/15 CHARTWELL MOLECULAR
090459 006 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 20MG Prescription No No AB 2018/07/16 ZYDUS PHARMS
206155 006 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 20MG Discontinued No No AB 2020/07/31 INDOCO
210022 006 ANDA OLANZAPINE OLANZAPINE TABLET;ORAL 20MG Prescription No No AB 2023/02/24 CADILA PHARMS 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
参考引用2
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