EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE |
203041 |
001 |
ANDA |
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
600MG;200MG;300MG |
No
|
Yes
|
2018/09/04
|
2018/09/04
|
AUROBINDO PHARMA |
Prescription |
EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE |
091215 |
001 |
ANDA |
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
600MG;200MG;300MG |
No
|
No
|
2018/11/09
|
2018/11/09
|
TEVA PHARMS USA |
Prescription |
TENOFOVIR DISOPROXIL FUMARATE |
206569 |
001 |
ANDA |
TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
150MG |
No
|
No
|
2018/11/27
|
2018/11/27
|
NORVIUM BIOSCIENCE |
Discontinued |
TENOFOVIR DISOPROXIL FUMARATE |
206569 |
002 |
ANDA |
TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
200MG |
No
|
No
|
2018/11/27
|
2018/11/27
|
NORVIUM BIOSCIENCE |
Discontinued |
TENOFOVIR DISOPROXIL FUMARATE |
206569 |
003 |
ANDA |
TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
250MG |
No
|
No
|
2018/11/27
|
2018/11/27
|
NORVIUM BIOSCIENCE |
Discontinued |
TENOFOVIR DISOPROXIL FUMARATE |
206569 |
004 |
ANDA |
TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
300MG |
No
|
No
|
2018/11/27
|
2018/11/27
|
NORVIUM BIOSCIENCE |
Discontinued |
DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE |
210787 |
001 |
NDA |
DOLUTEGRAVIR;LAMIVUDINE;TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
50MG; 300MG;300MG |
No
|
No
|
2019/02/01
(TA)
|
--
|
LAURUS LABS LTD |
None (Tentative Approval) |
EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE |
210649 |
001 |
NDA |
EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
400MG;300MG;300MG |
No
|
No
|
2019/03/15
|
2019/03/15
|
MACLEODS PHARMS LTD |
Discontinued |
DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE |
210796 |
001 |
NDA |
DOLUTEGRAVIR;LAMIVUDINE;TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
50MG/300MG/300MG |
No
|
No
|
2019/03/25
(TA)
|
--
|
MACLEODS PHARMS LTD |
None (Tentative Approval) |
EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE |
206894 |
001 |
ANDA |
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
600MG;200MG;300MG |
No
|
No
|
2019/06/03
|
2019/06/03
|
CIPLA |
Prescription |
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE |
212114 |
001 |
ANDA |
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
200MG;300MG |
No
|
No
|
2019/07/26
|
2019/07/26
|
LAURUS |
Prescription |
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE |
212689 |
001 |
ANDA |
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
200MG;300MG |
No
|
No
|
2020/02/28
|
2020/02/28
|
ZYDUS PHARMS |
Prescription |
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE |
212689 |
002 |
ANDA |
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
100MG;150MG |
No
|
No
|
2020/02/28
|
2021/07/01
|
ZYDUS PHARMS |
Prescription |
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE |
212689 |
003 |
ANDA |
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
133MG;200MG |
No
|
No
|
2020/02/28
|
2021/07/01
|
ZYDUS PHARMS |
Prescription |
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE |
212689 |
004 |
ANDA |
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
167MG;250MG |
No
|
No
|
2020/02/28
|
2021/07/01
|
ZYDUS PHARMS |
Prescription |
EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE |
212786 |
001 |
ANDA |
EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
600MG;300MG;300MG |
No
|
No
|
2020/05/14
|
2020/05/14
|
LAURUS |
Prescription |
EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE |
213038 |
001 |
ANDA |
EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
400MG;300MG;300MG |
No
|
No
|
2020/05/14
|
2020/05/14
|
LAURUS |
Prescription |
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE |
203442 |
001 |
ANDA |
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
200MG;300MG |
No
|
No
|
2020/05/15
|
2020/05/15
|
MACLEODS PHARMS LTD |
Prescription |
DOLUTEGRAVIR, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE |
213556 |
001 |
NDA |
DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
50MG; 300MG; 300MG |
No
|
No
|
2020/10/06
(TA)
|
--
|
SHANGHAI DESANA BIO-PHARMACEUTICALS CO LTD |
None (Tentative Approval) |
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE |
091055 |
001 |
ANDA |
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
200MG;300MG |
No
|
No
|
2021/01/13
|
2021/01/13
|
STRIDES PHARMA |
Prescription |