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 |
|---|
| 2024/12/04 |
SUPPL-3（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2024/12/04 |
SUPPL-2（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 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 |
|---|
| 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 |
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 |
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 | RLD | RS | TE 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 | RLD | RS | TE 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 | RLD | RS | TE 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 | RLD | RS | TE 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 | RLD | RS | TE 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 | RLD | RS | TE 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 |
