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 |
|---|
| 2020/11/23 |
SUPPL-1（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2019/06/03 |
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:EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 剂型/给药途径:TABLET;ORAL 规格:600MG;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 |
|---|
| 021937 |
001 |
NDA |
ATRIPLA |
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
600MG;200MG;300MG |
Discontinued |
Yes |
No |
AB |
2006/07/12
|
GILEAD SCIENCES |
| 203041 |
001 |
ANDA |
EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE |
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
600MG;200MG;300MG |
Prescription |
No |
Yes |
AB |
2018/09/04
|
AUROBINDO PHARMA |
| 091215 |
001 |
ANDA |
EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE |
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
600MG;200MG;300MG |
Prescription |
No |
No |
AB |
2018/11/09
|
TEVA PHARMS USA |
| 206894 |
001 |
ANDA |
EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE |
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
600MG;200MG;300MG |
Prescription |
No |
No |
AB |
2019/06/03
|
CIPLA |
| 204287 |
001 |
ANDA |
EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE |
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
600MG;200MG;300MG |
Prescription |
No |
No |
AB |
2021/09/13
|
MACLEODS PHARMS LTD |
| 213541 |
001 |
ANDA |
EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE |
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
600MG;200MG;300MG |
Prescription |
No |
No |
AB |
2021/12/22
|
LAURUS |
| 203053 |
001 |
ANDA |
EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE |
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
600MG;200MG;300MG |
Prescription |
No |
No |
AB |
2022/01/24
|
HETERO LABS LTD V |
| 201802 |
001 |
ANDA |
EFAVIRENZ; EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE |
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
600MG;200MG;300MG |
Discontinued |
No |
No |
AB |
2023/10/03
|
STRIDES PHARMA |
| 209061 |
001 |
ANDA |
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
600MG;200MG;300MG |
Discontinued |
No |
No |
AB |
2024/09/05
|
MYLAN |