药品注册申请号：203691
申请类型：ANDA (仿制药申请)
申请人：AMNEAL PHARMS
申请人全名：AMNEAL PHARMACEUTICALS
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 TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 5MG No No AB 2015/05/08 2015/05/08 Prescription
002 TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 20MG No No AB 2015/05/08 Prescription
003 TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 100MG No No AB 2015/05/08 Prescription
004 TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 140MG No No AB 2015/05/08 Prescription
005 TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 180MG No No AB 2015/05/08 Prescription
006 TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 250MG No No AB 2015/05/08 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
2022/01/26 SUPPL-8（补充） Approval Labeling STANDARD
2019/07/16 SUPPL-4（补充） Approval Labeling STANDARD
2016/01/12 SUPPL-1（补充） Approval Labeling STANDARD
2015/05/08 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:TEMOZOLOMIDE 剂型/给药途径:CAPSULE;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
021029 001 NDA TEMODAR TEMOZOLOMIDE CAPSULE;ORAL 5MG Discontinued Yes No AB 1999/08/11 MERCK SHARP DOHME
078879 001 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 5MG Discontinued No No AB 2010/03/01 HERITAGE
201742 001 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 5MG Prescription No No AB 2014/02/12 SUN PHARM
203691 001 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 5MG Prescription No No AB 2015/05/08 AMNEAL PHARMS
206413 001 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 5MG Prescription No No AB 2016/04/12 CHARTWELL
206309 001 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 5MG Prescription No No AB 2016/04/27 RISING
203490 001 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 5MG Discontinued No No AB 2016/07/13 ANI PHARMS
204639 001 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 5MG Prescription No No AB 2016/11/23 CHEMI SPA
201528 001 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 5MG Prescription No No AB 2017/02/27 ACCORD HLTHCARE
207658 001 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 5MG Prescription No No AB 2017/04/26 DEVA HOLDING AS
206750 001 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 5MG Prescription No No AB 2017/07/31 ZYDUS PHARMS
213328 001 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 5MG Discontinued No No AB 2021/11/23 NIVAGEN PHARMS INC
210030 001 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 5MG Prescription No No AB 2024/08/23 HETERO LABS LTD V
活性成分:TEMOZOLOMIDE 剂型/给药途径:CAPSULE;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
021029 002 NDA TEMODAR TEMOZOLOMIDE CAPSULE;ORAL 20MG Discontinued Yes No AB 1999/08/11 MERCK SHARP DOHME
078879 002 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 20MG Discontinued No No AB 2010/03/01 HERITAGE
201742 002 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 20MG Prescription No No AB 2014/02/12 SUN PHARM
203691 002 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 20MG Prescription No No AB 2015/05/08 AMNEAL PHARMS
206413 002 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 20MG Prescription No No AB 2016/04/12 CHARTWELL
206309 002 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 20MG Prescription No No AB 2016/04/27 RISING
203490 002 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 20MG Discontinued No No AB 2016/07/13 ANI PHARMS
204639 002 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 20MG Prescription No No AB 2016/11/23 CHEMI SPA
201528 002 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 20MG Prescription No No AB 2017/02/27 ACCORD HLTHCARE
207658 002 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 20MG Prescription No No AB 2017/04/26 DEVA HOLDING AS
206750 002 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 20MG Prescription No No AB 2017/07/31 ZYDUS PHARMS
213328 002 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 20MG Discontinued No No AB 2021/11/23 NIVAGEN PHARMS INC
210030 002 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 20MG Prescription No No AB 2024/08/23 HETERO LABS LTD V
活性成分:TEMOZOLOMIDE 剂型/给药途径:CAPSULE;ORAL 规格:100MG 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
021029 003 NDA TEMODAR TEMOZOLOMIDE CAPSULE;ORAL 100MG Discontinued Yes No AB 1999/08/11 MERCK SHARP DOHME
078879 003 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 100MG Discontinued No No AB 2010/03/01 HERITAGE
201742 003 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 100MG Prescription No No AB 2014/02/12 SUN PHARM
203691 003 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 100MG Prescription No No AB 2015/05/08 AMNEAL PHARMS
206413 003 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 100MG Prescription No No AB 2016/04/12 CHARTWELL
206309 003 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 100MG Prescription No No AB 2016/04/27 RISING
203490 003 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 100MG Discontinued No No AB 2016/07/13 ANI PHARMS
204639 003 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 100MG Prescription No No AB 2016/11/23 CHEMI SPA
201528 003 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 100MG Prescription No No AB 2017/02/27 ACCORD HLTHCARE
207658 003 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 100MG Prescription No No AB 2017/04/26 DEVA HOLDING AS
206750 003 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 100MG Prescription No No AB 2017/07/31 ZYDUS PHARMS
213328 003 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 100MG Discontinued No No AB 2021/11/23 NIVAGEN PHARMS INC
210030 003 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 100MG Prescription No No AB 2024/08/23 HETERO LABS LTD V
活性成分:TEMOZOLOMIDE 剂型/给药途径:CAPSULE;ORAL 规格:140MG 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
021029 005 NDA TEMODAR TEMOZOLOMIDE CAPSULE;ORAL 140MG Discontinued Yes No AB 2006/10/19 MERCK SHARP DOHME
078879 005 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 140MG Discontinued No No AB 2010/03/01 HERITAGE
201742 004 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 140MG Prescription No No AB 2014/02/12 SUN PHARM
203691 004 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 140MG Prescription No No AB 2015/05/08 AMNEAL PHARMS
206413 004 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 140MG Prescription No No AB 2016/04/12 CHARTWELL
206309 004 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 140MG Prescription No No AB 2016/04/27 RISING
203490 004 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 140MG Discontinued No No AB 2016/07/13 ANI PHARMS
204639 004 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 140MG Prescription No No AB 2016/11/23 CHEMI SPA
201528 004 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 140MG Prescription No No AB 2017/02/27 ACCORD HLTHCARE
207658 004 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 140MG Prescription No No AB 2017/04/26 DEVA HOLDING AS
206750 004 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 140MG Prescription No No AB 2017/07/31 ZYDUS PHARMS
213328 004 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 140MG Discontinued No No AB 2021/11/23 NIVAGEN PHARMS INC
210030 004 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 140MG Prescription No No AB 2024/08/23 HETERO LABS LTD V
活性成分:TEMOZOLOMIDE 剂型/给药途径:CAPSULE;ORAL 规格:180MG 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
021029 006 NDA TEMODAR TEMOZOLOMIDE CAPSULE;ORAL 180MG Discontinued Yes No AB 2006/10/19 MERCK SHARP DOHME
078879 006 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 180MG Discontinued No No AB 2010/03/01 HERITAGE
201742 005 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 180MG Prescription No No AB 2014/02/12 SUN PHARM
203691 005 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 180MG Prescription No No AB 2015/05/08 AMNEAL PHARMS
206413 005 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 180MG Prescription No No AB 2016/04/12 CHARTWELL
206309 005 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 180MG Prescription No No AB 2016/04/27 RISING
203490 005 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 180MG Discontinued No No AB 2016/07/13 ANI PHARMS
204639 005 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 180MG Prescription No No AB 2016/11/23 CHEMI SPA
201528 005 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 180MG Prescription No No AB 2017/02/27 ACCORD HLTHCARE
207658 005 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 180MG Prescription No No AB 2017/04/26 DEVA HOLDING AS
206750 005 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 180MG Prescription No No AB 2017/07/31 ZYDUS PHARMS
213328 005 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 180MG Discontinued No No AB 2021/11/23 NIVAGEN PHARMS INC
210030 005 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 180MG Prescription No No AB 2024/08/23 HETERO LABS LTD V
活性成分:TEMOZOLOMIDE 剂型/给药途径:CAPSULE;ORAL 规格:250MG 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
021029 004 NDA TEMODAR TEMOZOLOMIDE CAPSULE;ORAL 250MG Discontinued Yes No AB 1999/08/11 MERCK SHARP DOHME
078879 004 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 250MG Discontinued No No AB 2010/03/01 HERITAGE
201742 006 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 250MG Prescription No No AB 2014/02/12 SUN PHARM
203691 006 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 250MG Prescription No No AB 2015/05/08 AMNEAL PHARMS
206413 006 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 250MG Prescription No No AB 2016/04/12 CHARTWELL
206309 006 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 250MG Prescription No No AB 2016/04/27 RISING
204639 006 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 250MG Prescription No No AB 2016/11/23 CHEMI SPA
201528 006 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 250MG Prescription No Yes AB 2017/02/27 ACCORD HLTHCARE
207658 006 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 250MG Prescription No No AB 2017/04/26 DEVA HOLDING AS
206750 006 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 250MG Prescription No No AB 2017/07/31 ZYDUS PHARMS
213328 006 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 250MG Discontinued No No AB 2021/11/23 NIVAGEN PHARMS INC
210030 006 ANDA TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 250MG Prescription No No AB 2024/08/23 HETERO LABS LTD V
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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