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 |
|---|
| 2022/08/31 |
SUPPL-16（补充） |
Approval |
Manufacturing (CMC) |
UNKNOWN
|
|
|
| 2020/01/07 |
SUPPL-11（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2020/01/07 |
SUPPL-7（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2020/01/07 |
SUPPL-6（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2018/01/26 |
ORIG-2（原始申请） |
Approval |
|
STANDARD
|
|
|
| 2018/01/26 |
ORIG-1（原始申请） |
Approval |
|
|
|
|
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:TENOFOVIR DISOPROXIL FUMARATE 剂型/给药途径:TABLET;ORAL 规格: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 |
|---|
| 021356 |
001 |
NDA |
VIREAD |
TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
300MG |
Prescription |
Yes |
Yes |
AB |
2001/10/26
|
GILEAD SCIENCES INC |
| 091612 |
001 |
ANDA |
TENOFOVIR DISOPROXIL FUMARATE |
TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
300MG |
Prescription |
No |
No |
AB |
2015/03/18
|
TEVA PHARMS USA |
| 203232 |
001 |
ANDA |
TENOFOVIR DISOPROXIL FUMARATE |
TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
300MG |
Prescription |
No |
No |
AB |
2018/01/26
|
MACLEODS PHARMS LTD |
| 078800 |
001 |
ANDA |
TENOFOVIR DISOPROXIL FUMARATE |
TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
300MG |
Prescription |
No |
No |
AB |
2018/01/26
|
CIPLA |
| 090636 |
001 |
ANDA |
TENOFOVIR DISOPROXIL FUMARATE |
TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
300MG |
Prescription |
No |
No |
AB |
2018/01/26
|
HETERO LABS LTD III |
| 090647 |
004 |
ANDA |
TENOFOVIR DISOPROXIL FUMARATE |
TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
300MG |
Prescription |
No |
No |
AB |
2018/01/26
|
AUROBINDO PHARMA |
| 090742 |
001 |
ANDA |
TENOFOVIR DISOPROXIL FUMARATE |
TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
300MG |
Prescription |
No |
No |
AB |
2018/01/26
|
STRIDES PHARMA |
| 209550 |
001 |
ANDA |
TENOFOVIR DISOPROXIL FUMARATE |
TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
300MG |
Discontinued |
No |
No |
AB |
2018/02/26
|
CHARTWELL RX |
| 209498 |
003 |
ANDA |
TENOFOVIR DISOPROXIL FUMARATE |
TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
300MG |
Prescription |
No |
No |
AB |
2018/03/02
|
QILU |
| 206481 |
001 |
ANDA |
TENOFOVIR DISOPROXIL FUMARATE |
TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
300MG |
Prescription |
No |
No |
AB |
2018/07/26
|
CHARTWELL |
| 211337 |
001 |
ANDA |
TENOFOVIR DISOPROXIL FUMARATE |
TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
300MG |
Prescription |
No |
No |
AB |
2023/03/02
|
REYOUNG |
| 079071 |
001 |
ANDA |
TENOFOVIR DISOPROXIL FUMARATE |
TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
300MG |
Prescription |
No |
No |
AB |
2024/02/29
|
NORVIUM BIOSCIENCE |
活性成分:TENOFOVIR DISOPROXIL FUMARATE 剂型/给药途径:TABLET;ORAL 规格: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 |
|---|
| 021356 |
001 |
NDA |
VIREAD |
TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
300MG |
Prescription |
Yes |
Yes |
AB |
2001/10/26
|
GILEAD SCIENCES INC |
| 091612 |
001 |
ANDA |
TENOFOVIR DISOPROXIL FUMARATE |
TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
300MG |
Prescription |
No |
No |
AB |
2015/03/18
|
TEVA PHARMS USA |
| 203232 |
001 |
ANDA |
TENOFOVIR DISOPROXIL FUMARATE |
TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
300MG |
Prescription |
No |
No |
AB |
2018/01/26
|
MACLEODS PHARMS LTD |
| 078800 |
001 |
ANDA |
TENOFOVIR DISOPROXIL FUMARATE |
TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
300MG |
Prescription |
No |
No |
AB |
2018/01/26
|
CIPLA |
| 090636 |
001 |
ANDA |
TENOFOVIR DISOPROXIL FUMARATE |
TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
300MG |
Prescription |
No |
No |
AB |
2018/01/26
|
HETERO LABS LTD III |
| 090647 |
004 |
ANDA |
TENOFOVIR DISOPROXIL FUMARATE |
TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
300MG |
Prescription |
No |
No |
AB |
2018/01/26
|
AUROBINDO PHARMA |
| 090742 |
001 |
ANDA |
TENOFOVIR DISOPROXIL FUMARATE |
TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
300MG |
Prescription |
No |
No |
AB |
2018/01/26
|
STRIDES PHARMA |
| 209550 |
001 |
ANDA |
TENOFOVIR DISOPROXIL FUMARATE |
TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
300MG |
Discontinued |
No |
No |
AB |
2018/02/26
|
CHARTWELL RX |
| 209498 |
003 |
ANDA |
TENOFOVIR DISOPROXIL FUMARATE |
TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
300MG |
Prescription |
No |
No |
AB |
2018/03/02
|
QILU |
| 206481 |
001 |
ANDA |
TENOFOVIR DISOPROXIL FUMARATE |
TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
300MG |
Prescription |
No |
No |
AB |
2018/07/26
|
CHARTWELL |
| 211337 |
001 |
ANDA |
TENOFOVIR DISOPROXIL FUMARATE |
TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
300MG |
Prescription |
No |
No |
AB |
2023/03/02
|
REYOUNG |
| 079071 |
001 |
ANDA |
TENOFOVIR DISOPROXIL FUMARATE |
TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
300MG |
Prescription |
No |
No |
AB |
2024/02/29
|
NORVIUM BIOSCIENCE |
