CYANOCOBALAMIN |
209255 |
001 |
ANDA |
CYANOCOBALAMIN |
INJECTABLE;INJECTION |
1MG/ML |
No
|
No
|
2018/12/18
|
2018/12/18
|
VITRUVIAS THERAP |
Prescription |
CYANOCOBALAMIN |
209429 |
001 |
ANDA |
CYANOCOBALAMIN |
INJECTABLE;INJECTION |
1MG/ML |
No
|
No
|
2018/12/18
|
2018/12/18
|
SOMERSET THERAPS LLC |
Prescription |
PREGABALIN |
206942 |
001 |
ANDA |
PREGABALIN |
CAPSULE;ORAL |
25MG |
No
|
No
|
2019/01/04
(TA)
|
--
|
TORRENT PHARMS LTD |
None (Tentative Approval) |
PREGABALIN |
206942 |
002 |
ANDA |
PREGABALIN |
CAPSULE;ORAL |
50MG |
No
|
No
|
2019/01/04
(TA)
|
--
|
TORRENT PHARMS LTD |
None (Tentative Approval) |
PREGABALIN |
206942 |
003 |
ANDA |
PREGABALIN |
CAPSULE;ORAL |
75MG |
No
|
No
|
2019/01/04
(TA)
|
--
|
TORRENT PHARMS LTD |
None (Tentative Approval) |
PREGABALIN |
206942 |
004 |
ANDA |
PREGABALIN |
CAPSULE;ORAL |
100MG |
No
|
No
|
2019/01/04
(TA)
|
--
|
TORRENT PHARMS LTD |
None (Tentative Approval) |
PREGABALIN |
206942 |
005 |
ANDA |
PREGABALIN |
CAPSULE;ORAL |
150MG |
No
|
No
|
2019/01/04
(TA)
|
--
|
TORRENT PHARMS LTD |
None (Tentative Approval) |
PREGABALIN |
206942 |
006 |
ANDA |
PREGABALIN |
CAPSULE;ORAL |
200MG |
No
|
No
|
2019/01/04
(TA)
|
--
|
TORRENT PHARMS LTD |
None (Tentative Approval) |
PREGABALIN |
206942 |
007 |
ANDA |
PREGABALIN |
CAPSULE;ORAL |
225MG |
No
|
No
|
2019/01/04
(TA)
|
--
|
TORRENT PHARMS LTD |
None (Tentative Approval) |
PREGABALIN |
206942 |
008 |
ANDA |
PREGABALIN |
CAPSULE;ORAL |
300MG |
No
|
No
|
2019/01/04
(TA)
|
--
|
TORRENT PHARMS LTD |
None (Tentative Approval) |
BALVERSA |
212018 |
001 |
NDA |
ERDAFITINIB |
TABLET;ORAL |
3MG |
Yes
|
No
|
2019/04/12
|
2019/04/12
|
JANSSEN BIOTECH |
Prescription |
BALVERSA |
212018 |
002 |
NDA |
ERDAFITINIB |
TABLET;ORAL |
4MG |
Yes
|
No
|
2019/04/12
|
2019/04/12
|
JANSSEN BIOTECH |
Prescription |
BALVERSA |
212018 |
003 |
NDA |
ERDAFITINIB |
TABLET;ORAL |
5MG |
Yes
|
Yes
|
2019/04/12
|
2019/04/12
|
JANSSEN BIOTECH |
Prescription |
PREGABALIN |
091219 |
001 |
ANDA |
PREGABALIN |
CAPSULE;ORAL |
25MG |
No
|
No
|
2019/07/19
|
2019/07/19
|
TEVA PHARMS |
Prescription |
PREGABALIN |
091219 |
002 |
ANDA |
PREGABALIN |
CAPSULE;ORAL |
50MG |
No
|
No
|
2019/07/19
|
2019/07/19
|
TEVA PHARMS |
Prescription |
PREGABALIN |
091224 |
001 |
ANDA |
PREGABALIN |
CAPSULE;ORAL |
75MG |
No
|
No
|
2019/07/19
|
2019/07/19
|
TEVA PHARMS |
Prescription |
PREGABALIN |
091224 |
002 |
ANDA |
PREGABALIN |
CAPSULE;ORAL |
100MG |
No
|
No
|
2019/07/19
|
2019/07/19
|
TEVA PHARMS |
Prescription |
PREGABALIN |
091224 |
003 |
ANDA |
PREGABALIN |
CAPSULE;ORAL |
150MG |
No
|
No
|
2019/07/19
|
2019/07/19
|
TEVA PHARMS |
Prescription |
PREGABALIN |
091224 |
004 |
ANDA |
PREGABALIN |
CAPSULE;ORAL |
200MG |
No
|
No
|
2019/07/19
|
2019/07/19
|
TEVA PHARMS |
Prescription |
PREGABALIN |
091224 |
005 |
ANDA |
PREGABALIN |
CAPSULE;ORAL |
225MG |
No
|
No
|
2019/07/19
|
2019/07/19
|
TEVA PHARMS |
Prescription |