| EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE |
211640 |
001 |
ANDA |
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
100MG;150MG |
No
|
No
|
2023/03/09
|
2023/03/09
|
AUROBINDO PHARMA LTD |
Prescription |
| EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE |
211640 |
002 |
ANDA |
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
133MG;200MG |
No
|
No
|
2023/03/09
|
2023/03/09
|
AUROBINDO PHARMA LTD |
Prescription |
| EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE |
211640 |
003 |
ANDA |
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
167MG;250MG |
No
|
No
|
2023/03/09
|
2023/03/09
|
AUROBINDO PHARMA LTD |
Prescription |
| EMTRICITABINE |
079188 |
001 |
ANDA |
EMTRICITABINE |
CAPSULE;ORAL |
200MG |
No
|
No
|
2023/03/15
|
2023/03/15
|
AUROBINDO PHARMA LTD |
Prescription |
| DOLUTEGRAVIR, EMTRICITABINE and TENOFOVIR ALAFENAMIDE |
215448 |
001 |
NDA |
DOLUTEGRAVIR, EMTRICITABINE and TENOFOVIR ALAFENAMIDE |
TABLET; ORAL |
50MG/200MG/25MG |
No
|
No
|
2023/05/26
(TA)
|
--
|
AUROBINDO PHARMA USA |
None (Tentative Approval) |
| EFAVIRENZ; EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE |
201802 |
001 |
ANDA |
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
600MG;200MG;300MG |
No
|
No
|
2023/10/03
|
2023/10/03
|
STRIDES PHARMA |
Discontinued |
| EFAVIRENZ; EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE |
201802 |
002 |
ANDA |
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
300MG |
No
|
No
|
2023/10/03
|
--
|
STRIDES PHARMA |
Prescription |
| EFAVIRENZ; EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE |
201802 |
003 |
ANDA |
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
600MG |
No
|
No
|
2023/10/03
|
--
|
STRIDES PHARMA |
Prescription |
| EMTRICITABINE AND TENOFOVIR ALAFENAMIDE |
211148 |
001 |
ANDA |
EMTRICITABINE, TENOFOVIR ALAFENAMIDE |
TABLET; ORAL |
10MG |
No
|
No
|
2024/01/02
(TA)
|
--
|
MYLAN LABS LTD |
None (Tentative Approval) |
| EMTRICITABINE AND TENOFOVIR ALAFENAMIDE |
211148 |
002 |
ANDA |
EMTRICITABINE, TENOFOVIR ALAFENAMIDE |
TABLET; ORAL |
15MG |
No
|
No
|
2024/01/02
(TA)
|
--
|
MYLAN LABS LTD |
None (Tentative Approval) |
| EMTRICITABINE AND TENOFOVIR ALAFENAMIDE |
211148 |
003 |
ANDA |
EMTRICITABINE, TENOFOVIR ALAFENAMIDE |
TABLET; ORAL |
25MG |
No
|
No
|
2024/01/02
(TA)
|
--
|
MYLAN LABS LTD |
None (Tentative Approval) |
| EMTRICITABINE AND TENOFOVIR ALAFENAMIDE |
211148 |
004 |
ANDA |
EMTRICITABINE, TENOFOVIR ALAFENAMIDE |
TABLET; ORAL |
120MG |
No
|
No
|
2024/01/02
(TA)
|
--
|
MYLAN LABS LTD |
None (Tentative Approval) |
| EMTRICITABINE AND TENOFOVIR ALAFENAMIDE |
211148 |
005 |
ANDA |
EMTRICITABINE, TENOFOVIR ALAFENAMIDE |
TABLET; ORAL |
200MG |
No
|
No
|
2024/01/02
(TA)
|
--
|
MYLAN LABS LTD |
None (Tentative Approval) |
| EFAVIRENZ, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE |
213509 |
001 |
NDA |
EFAVIRENZ, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE |
TABLET; ORAL |
400MG; 200MG; 25MG |
No
|
No
|
2024/03/22
(TA)
|
--
|
MYLAN |
Prescription |