BUPRENORPHINE HYDROCHLORIDE |
201066 |
002 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE |
TABLET;SUBLINGUAL |
EQ 8MG BASE |
No
|
No
|
2015/03/06
|
2015/03/06
|
NORVIUM BIOSCIENCE |
Discontinued |
BUPRENORPHINE HYDROCHLORIDE |
090279 |
001 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE |
TABLET;SUBLINGUAL |
EQ 2MG BASE |
No
|
No
|
2015/06/10
|
2015/06/10
|
RUBICON |
Prescription |
BUPRENORPHINE HYDROCHLORIDE |
090279 |
002 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE |
TABLET;SUBLINGUAL |
EQ 8MG BASE |
No
|
No
|
2015/06/10
|
2015/06/10
|
RUBICON |
Prescription |
BUPRENORPHINE HYDROCHLORIDE |
206586 |
001 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 0.3MG BASE/ML |
No
|
Yes
|
2015/07/28
|
2015/07/28
|
ENDO OPERATIONS |
Prescription |
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 USA CORP |
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 USA CORP |
Prescription |
BUPRENORPHINE HYDROCHLORIDE |
201760 |
001 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE |
TABLET;SUBLINGUAL |
EQ 2MG BASE |
No
|
No
|
2016/01/29
|
2016/01/29
|
SUN PHARM |
Prescription |
BUPRENORPHINE HYDROCHLORIDE |
201760 |
002 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE |
TABLET;SUBLINGUAL |
EQ 8MG BASE |
No
|
No
|
2016/01/29
|
2016/01/29
|
SUN PHARM |
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 |
BUPRENORPHINE HYDROCHLORIDE |
207276 |
001 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE |
TABLET;SUBLINGUAL |
EQ 2MG BASE |
No
|
No
|
2017/03/27
|
2017/03/27
|
RHODES PHARMS |
Prescription |
BUPRENORPHINE HYDROCHLORIDE |
207276 |
002 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE |
TABLET;SUBLINGUAL |
EQ 8MG BASE |
No
|
No
|
2017/03/27
|
2017/03/27
|
RHODES PHARMS |
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 |