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 |
2024/07/11 |
SUPPL-1(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2021/06/16 |
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 | RLD | RS | TE 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 |