药品注册申请号:212689
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 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 200MG;300MG No No AB;AB 2020/02/28 2020/02/28 Prescription
002 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 100MG;150MG No No AB;AB 2021/07/01 Prescription
003 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 133MG;200MG No No AB;AB 2021/07/01 Prescription
004 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 167MG;250MG No No AB;AB 2021/07/01 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
2021/07/01 ORIG-2(原始申请) Approval STANDARD
2021/03/08 SUPPL-1(补充) Approval Labeling STANDARD
2020/02/28 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
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
与本品治疗等效的药品
活性成分:EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 剂型/给药途径:TABLET;ORAL 规格:200MG;300MG 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
021752 001 NDA TRUVADA EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 200MG;300MG Prescription Yes Yes AB 2004/08/02 GILEAD
090894 001 ANDA EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 200MG;300MG Prescription No No AB 2017/06/08 TEVA PHARMS USA
090513 001 ANDA EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 200MG;300MG Prescription No No AB 2018/01/26 AUROBINDO PHARMA
206436 001 ANDA EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 200MG;300MG Prescription No No AB 2018/04/09 MYLAN
209721 004 ANDA EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 200MG;300MG Prescription No No AB 2018/08/22 AMNEAL PHARMS CO
212114 001 ANDA EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 200MG;300MG Prescription No No AB 2019/07/26 LAURUS
212689 001 ANDA EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 200MG;300MG Prescription No No AB 2020/02/28 ZYDUS PHARMS
203442 001 ANDA EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 200MG;300MG Prescription No No AB 2020/05/15 MACLEODS PHARMS LTD
091055 001 ANDA EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 200MG;300MG Prescription No No AB 2021/01/13 STRIDES PHARMA
090958 001 ANDA EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 200MG;300MG Discontinued No No AB 2021/04/02 CIPLA
204131 001 ANDA EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 200MG;300MG Prescription No No AB 2021/06/04 CHARTWELL RX
208740 001 ANDA EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 200MG;300MG Discontinued No No AB 2021/06/16 APOTEX
201806 001 ANDA EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 200MG;300MG Prescription No No AB 2021/10/07 HETERO LABS LTD III
活性成分:EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 剂型/给药途径:TABLET;ORAL 规格:200MG;300MG 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
021752 001 NDA TRUVADA EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 200MG;300MG Prescription Yes Yes AB 2004/08/02 GILEAD
090894 001 ANDA EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 200MG;300MG Prescription No No AB 2017/06/08 TEVA PHARMS USA
090513 001 ANDA EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 200MG;300MG Prescription No No AB 2018/01/26 AUROBINDO PHARMA
206436 001 ANDA EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 200MG;300MG Prescription No No AB 2018/04/09 MYLAN
209721 004 ANDA EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 200MG;300MG Prescription No No AB 2018/08/22 AMNEAL PHARMS CO
212114 001 ANDA EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 200MG;300MG Prescription No No AB 2019/07/26 LAURUS
212689 001 ANDA EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 200MG;300MG Prescription No No AB 2020/02/28 ZYDUS PHARMS
203442 001 ANDA EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 200MG;300MG Prescription No No AB 2020/05/15 MACLEODS PHARMS LTD
091055 001 ANDA EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 200MG;300MG Prescription No No AB 2021/01/13 STRIDES PHARMA
090958 001 ANDA EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 200MG;300MG Discontinued No No AB 2021/04/02 CIPLA
204131 001 ANDA EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 200MG;300MG Prescription No No AB 2021/06/04 CHARTWELL RX
208740 001 ANDA EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 200MG;300MG Discontinued No No AB 2021/06/16 APOTEX
201806 001 ANDA EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 200MG;300MG Prescription No No AB 2021/10/07 HETERO LABS LTD III
活性成分:EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 剂型/给药途径:TABLET;ORAL 规格:100MG;150MG 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
021752 002 NDA TRUVADA EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 100MG;150MG Prescription Yes No AB 2016/03/10 GILEAD
209721 001 ANDA EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 100MG;150MG Prescription No No AB 2018/08/22 AMNEAL PHARMS CO
212689 002 ANDA EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 100MG;150MG Prescription No No AB 2021/07/01 ZYDUS PHARMS
211640 001 ANDA EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 100MG;150MG Prescription No No AB 2023/03/09 AUROBINDO PHARMA LTD
活性成分:EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 剂型/给药途径:TABLET;ORAL 规格:100MG;150MG 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
021752 002 NDA TRUVADA EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 100MG;150MG Prescription Yes No AB 2016/03/10 GILEAD
209721 001 ANDA EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 100MG;150MG Prescription No No AB 2018/08/22 AMNEAL PHARMS CO
212689 002 ANDA EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 100MG;150MG Prescription No No AB 2021/07/01 ZYDUS PHARMS
211640 001 ANDA EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 100MG;150MG Prescription No No AB 2023/03/09 AUROBINDO PHARMA LTD
活性成分:EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 剂型/给药途径:TABLET;ORAL 规格:133MG;200MG 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
021752 003 NDA TRUVADA EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 133MG;200MG Prescription Yes No AB 2016/03/10 GILEAD
209721 002 ANDA EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 133MG;200MG Prescription No No AB 2018/08/22 AMNEAL PHARMS CO
212689 003 ANDA EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 133MG;200MG Prescription No No AB 2021/07/01 ZYDUS PHARMS
211640 002 ANDA EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 133MG;200MG Prescription No No AB 2023/03/09 AUROBINDO PHARMA LTD
活性成分:EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 剂型/给药途径:TABLET;ORAL 规格:133MG;200MG 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
021752 003 NDA TRUVADA EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 133MG;200MG Prescription Yes No AB 2016/03/10 GILEAD
209721 002 ANDA EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 133MG;200MG Prescription No No AB 2018/08/22 AMNEAL PHARMS CO
212689 003 ANDA EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 133MG;200MG Prescription No No AB 2021/07/01 ZYDUS PHARMS
211640 002 ANDA EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 133MG;200MG Prescription No No AB 2023/03/09 AUROBINDO PHARMA LTD
活性成分:EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 剂型/给药途径:TABLET;ORAL 规格:167MG;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
021752 004 NDA TRUVADA EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 167MG;250MG Prescription Yes No AB 2016/03/10 GILEAD
209721 003 ANDA EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 167MG;250MG Prescription No No AB 2018/08/22 AMNEAL PHARMS CO
212689 004 ANDA EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 167MG;250MG Prescription No No AB 2021/07/01 ZYDUS PHARMS
211640 003 ANDA EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 167MG;250MG Prescription No No AB 2023/03/09 AUROBINDO PHARMA LTD
活性成分:EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 剂型/给药途径:TABLET;ORAL 规格:167MG;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
021752 004 NDA TRUVADA EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 167MG;250MG Prescription Yes No AB 2016/03/10 GILEAD
209721 003 ANDA EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 167MG;250MG Prescription No No AB 2018/08/22 AMNEAL PHARMS CO
212689 004 ANDA EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 167MG;250MG Prescription No No AB 2021/07/01 ZYDUS PHARMS
211640 003 ANDA EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 167MG;250MG Prescription No No AB 2023/03/09 AUROBINDO PHARMA LTD
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