药品注册申请号：208578
申请类型：ANDA (仿制药申请)
申请人：ZYDUS PHARMS
申请人全名：ZYDUS PHARMACEUTICALS USA 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 OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE CAPSULE;ORAL EQ 30MG BASE No No AB 2017/02/24 2017/02/24 Prescription
002 OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE CAPSULE;ORAL EQ 45MG BASE No No AB 2017/02/24 Prescription
003 OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE CAPSULE;ORAL EQ 75MG BASE No No AB 2017/02/24 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
2017/02/24 ORIG-1（原始申请） Approval 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
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:OSELTAMIVIR PHOSPHATE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 30MG BASE 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
021087 003 NDA TAMIFLU OSELTAMIVIR PHOSPHATE CAPSULE;ORAL EQ 30MG BASE Prescription Yes No AB 2007/07/02 ROCHE
202595 001 ANDA OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE CAPSULE;ORAL EQ 30MG BASE Prescription No No AB 2016/08/03 NATCO
208578 001 ANDA OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE CAPSULE;ORAL EQ 30MG BASE Prescription No No AB 2017/02/24 ZYDUS PHARMS
209093 001 ANDA OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE CAPSULE;ORAL EQ 30MG BASE Prescription No No AB 2017/05/17 AMNEAL PHARMS
207211 001 ANDA OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE CAPSULE;ORAL EQ 30MG BASE Prescription No No AB 2017/09/14 MACLEODS PHARMS LTD
208348 001 ANDA OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE CAPSULE;ORAL EQ 30MG BASE Prescription No No AB 2018/01/09 LUPIN
209438 001 ANDA OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE CAPSULE;ORAL EQ 30MG BASE Prescription No No AB 2018/02/23 HETERO LABS LTD III
209421 001 ANDA OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE CAPSULE;ORAL EQ 30MG BASE Prescription No No AB 2018/06/08 STRIDES PHARMA
211823 001 ANDA OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE CAPSULE;ORAL EQ 30MG BASE Prescription No No AB 2019/06/24 ALEMBIC
212739 001 ANDA OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE CAPSULE;ORAL EQ 30MG BASE Prescription No No AB 2020/03/04 SUNSHINE
212544 001 ANDA OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE CAPSULE;ORAL EQ 30MG BASE Prescription No No AB 2020/05/20 MSN
215208 001 ANDA OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE CAPSULE;ORAL EQ 30MG BASE Prescription No No AB 2021/10/01 EPIC PHARMA LLC
214726 001 ANDA OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE CAPSULE;ORAL EQ 30MG BASE Discontinued No No AB 2022/07/25 ACCORD HLTHCARE
217467 001 ANDA OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE CAPSULE;ORAL EQ 30MG BASE Prescription No No AB 2023/10/03 INVAGEN PHARMS
218565 001 ANDA OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE CAPSULE;ORAL EQ 30MG BASE Prescription No No AB 2024/05/01 LAURUS
217133 001 ANDA OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE CAPSULE;ORAL EQ 30MG BASE Prescription No No AB 2024/10/30 NANJING DAOQUN
217451 001 ANDA OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE CAPSULE;ORAL EQ 30MG BASE Prescription No No AB 2024/12/03 CEDIPROF INC
活性成分:OSELTAMIVIR PHOSPHATE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 45MG BASE 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
021087 002 NDA TAMIFLU OSELTAMIVIR PHOSPHATE CAPSULE;ORAL EQ 45MG BASE Prescription Yes No AB 2007/07/02 ROCHE
202595 002 ANDA OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE CAPSULE;ORAL EQ 45MG BASE Prescription No No AB 2016/08/03 NATCO
208578 002 ANDA OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE CAPSULE;ORAL EQ 45MG BASE Prescription No No AB 2017/02/24 ZYDUS PHARMS
209093 002 ANDA OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE CAPSULE;ORAL EQ 45MG BASE Prescription No No AB 2017/05/17 AMNEAL PHARMS
207211 002 ANDA OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE CAPSULE;ORAL EQ 45MG BASE Prescription No No AB 2017/09/14 MACLEODS PHARMS LTD
208348 002 ANDA OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE CAPSULE;ORAL EQ 45MG BASE Prescription No No AB 2018/01/09 LUPIN
209438 002 ANDA OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE CAPSULE;ORAL EQ 45MG BASE Prescription No No AB 2018/02/23 HETERO LABS LTD III
209421 002 ANDA OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE CAPSULE;ORAL EQ 45MG BASE Prescription No No AB 2018/06/08 STRIDES PHARMA
211823 002 ANDA OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE CAPSULE;ORAL EQ 45MG BASE Prescription No No AB 2019/06/24 ALEMBIC
212739 002 ANDA OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE CAPSULE;ORAL EQ 45MG BASE Prescription No No AB 2020/03/04 SUNSHINE
212544 002 ANDA OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE CAPSULE;ORAL EQ 45MG BASE Prescription No No AB 2020/05/20 MSN
215208 002 ANDA OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE CAPSULE;ORAL EQ 45MG BASE Prescription No No AB 2021/10/01 EPIC PHARMA LLC
214726 002 ANDA OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE CAPSULE;ORAL EQ 45MG BASE Discontinued No No AB 2022/07/25 ACCORD HLTHCARE
217467 002 ANDA OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE CAPSULE;ORAL EQ 45MG BASE Prescription No No AB 2023/10/03 INVAGEN PHARMS
218565 002 ANDA OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE CAPSULE;ORAL EQ 45MG BASE Prescription No No AB 2024/05/01 LAURUS
217451 002 ANDA OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE CAPSULE;ORAL EQ 45MG BASE Prescription No No AB 2024/12/03 CEDIPROF INC
活性成分:OSELTAMIVIR PHOSPHATE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 75MG BASE 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
021087 001 NDA TAMIFLU OSELTAMIVIR PHOSPHATE CAPSULE;ORAL EQ 75MG BASE Prescription Yes Yes AB 1999/10/27 ROCHE
202595 003 ANDA OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB 2016/08/03 NATCO
208578 003 ANDA OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB 2017/02/24 ZYDUS PHARMS
209093 003 ANDA OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB 2017/05/17 AMNEAL PHARMS
207211 003 ANDA OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB 2017/09/14 MACLEODS PHARMS LTD
208348 003 ANDA OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB 2018/01/09 LUPIN
209438 003 ANDA OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB 2018/02/23 HETERO LABS LTD III
209421 003 ANDA OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB 2018/06/08 STRIDES PHARMA
211823 003 ANDA OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB 2019/06/24 ALEMBIC
212739 003 ANDA OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB 2020/03/04 SUNSHINE
212544 003 ANDA OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB 2020/05/20 MSN
215208 003 ANDA OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB 2021/10/01 EPIC PHARMA LLC
214726 003 ANDA OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE CAPSULE;ORAL EQ 75MG BASE Discontinued No No AB 2022/07/25 ACCORD HLTHCARE
217467 003 ANDA OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB 2023/10/03 INVAGEN PHARMS
218009 001 ANDA OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB 2023/11/24 HAINAN POLY
218565 003 ANDA OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB 2024/05/01 LAURUS
217133 002 ANDA OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB 2024/10/30 NANJING DAOQUN
217451 003 ANDA OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB 2024/12/03 CEDIPROF INC
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药品NDC数据与药品包装、标签说明书
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