| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
091149 |
001 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
TABLET;SUBLINGUAL |
EQ 2MG BASE;EQ 0.5MG BASE |
No
|
No
|
2014/09/08
|
2014/09/08
|
TEVA PHARMS USA |
Discontinued |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
091149 |
002 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
TABLET;SUBLINGUAL |
EQ 8MG BASE;EQ 2MG BASE |
No
|
No
|
2014/09/08
|
2014/09/08
|
TEVA PHARMS USA |
Discontinued |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
204431 |
001 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
TABLET;SUBLINGUAL |
EQ 2MG BASE;EQ 0.5MG BASE |
No
|
No
|
2015/10/16
|
2015/10/16
|
ETHYPHARM |
Prescription |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
204431 |
002 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
TABLET;SUBLINGUAL |
EQ 8MG BASE;EQ 2MG BASE |
No
|
No
|
2015/10/16
|
2015/10/16
|
ETHYPHARM |
Prescription |
| NALOXONE HYDROCHLORIDE |
205014 |
001 |
ANDA |
NALOXONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.4MG/ML |
No
|
No
|
2016/06/29
|
2016/06/29
|
MYLAN INSTITUTIONAL |
Prescription |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
201633 |
001 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
TABLET;SUBLINGUAL |
EQ 2MG BASE;EQ 0.5MG BASE |
No
|
No
|
2016/08/05
|
2016/08/05
|
SUN PHARM |
Prescription |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
201633 |
002 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
TABLET;SUBLINGUAL |
EQ 8MG BASE;EQ 2MG BASE |
No
|
No
|
2016/08/05
|
2016/08/05
|
SUN PHARM |
Prescription |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
205022 |
001 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
TABLET;SUBLINGUAL |
EQ 2MG BASE;EQ 0.5MG BASE |
No
|
No
|
2016/09/19
|
2016/09/19
|
LANNETT CO INC |
Prescription |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
205022 |
002 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
TABLET;SUBLINGUAL |
EQ 8MG BASE;EQ 2MG BASE |
No
|
No
|
2016/09/19
|
2016/09/19
|
LANNETT CO INC |
Prescription |
| NALOXONE HYDROCHLORIDE |
208871 |
001 |
ANDA |
NALOXONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.4MG/ML |
No
|
No
|
2017/02/28
|
2017/02/28
|
RISING |
Prescription |
| NALOXONE HYDROCHLORIDE |
208872 |
001 |
ANDA |
NALOXONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.4MG/ML |
No
|
No
|
2017/03/14
|
2017/03/14
|
RISING |
Prescription |
| NALOXONE HYDROCHLORIDE |
207634 |
001 |
ANDA |
NALOXONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.4MG/ML |
No
|
No
|
2017/07/26
|
2017/07/26
|
SOMERSET THERAPS LLC |
Prescription |
| NALOXONE HYDROCHLORIDE |
207633 |
001 |
ANDA |
NALOXONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.4MG/ML |
No
|
No
|
2017/08/08
|
2017/08/08
|
SOMERSET THERAPS LLC |
Prescription |
| BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
204383 |
001 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
FILM;BUCCAL, SUBLINGUAL |
EQ 8MG BASE;EQ 2MG BASE |
No
|
No
|
2017/10/24
(TA)
|
--
|
ACTAVIS LABS UT INC |
None (Tentative Approval) |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
207000 |
001 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
TABLET;SUBLINGUAL |
EQ 2MG BASE;EQ 0.5MG BASE |
No
|
No
|
2017/12/13
|
2017/12/13
|
SPECGX LLC |
Prescription |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
207000 |
002 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
TABLET;SUBLINGUAL |
EQ 8MG BASE;EQ 2MG BASE |
No
|
No
|
2017/12/13
|
2017/12/13
|
SPECGX LLC |
Prescription |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
205299 |
001 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
FILM;BUCCAL, SUBLINGUAL |
EQ 2MG BASE;EQ 0.5MG BASE |
No
|
No
|
2018/06/14
|
2018/06/14
|
DR REDDYS LABS SA |
Prescription |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
205299 |
002 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
FILM;BUCCAL, SUBLINGUAL |
EQ 8MG BASE;EQ 2MG BASE |
No
|
No
|
2018/06/14
|
2018/06/14
|
DR REDDYS LABS SA |
Prescription |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
205806 |
001 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
FILM;BUCCAL, SUBLINGUAL |
EQ 4MG BASE;EQ 1MG BASE |
No
|
No
|
2018/06/14
|
2018/06/14
|
DR REDDYS LABS SA |
Prescription |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
205806 |
002 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
FILM;BUCCAL, SUBLINGUAL |
EQ 12MG BASE;EQ 3MG BASE |
No
|
No
|
2018/06/14
|
2018/06/14
|
DR REDDYS LABS SA |
Prescription |