BUPRENORPHINE HYDROCHLORIDE |
211594 |
002 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE |
FILM;BUCCAL |
EQ 0.15MG BASE |
No
|
No
|
2021/08/03
|
2021/08/03
|
ALVOGEN |
Discontinued |
BUPRENORPHINE HYDROCHLORIDE |
211594 |
003 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE |
FILM;BUCCAL |
EQ 0.3MG BASE |
No
|
No
|
2021/08/03
|
2021/08/03
|
ALVOGEN |
Discontinued |
BUPRENORPHINE HYDROCHLORIDE |
211594 |
004 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE |
FILM;BUCCAL |
EQ 0.45MG BASE |
No
|
No
|
2021/08/03
|
2021/08/03
|
ALVOGEN |
Discontinued |
BUPRENORPHINE HYDROCHLORIDE |
211594 |
005 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE |
FILM;BUCCAL |
EQ 0.6MG BASE |
No
|
No
|
2021/08/03
|
2021/08/03
|
ALVOGEN |
Discontinued |
BUPRENORPHINE HYDROCHLORIDE |
211594 |
006 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE |
FILM;BUCCAL |
EQ 0.75MG BASE |
No
|
No
|
2021/08/03
|
2021/08/03
|
ALVOGEN |
Discontinued |
BUPRENORPHINE HYDROCHLORIDE |
211594 |
007 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE |
FILM;BUCCAL |
EQ 0.9MG BASE |
No
|
No
|
2021/08/03
|
2021/08/03
|
ALVOGEN |
Discontinued |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
212756 |
001 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
FILM;BUCCAL, SUBLINGUAL |
EQ 8MG BASE;EQ 2MG BASE |
No
|
No
|
2022/06/02
|
2022/06/02
|
AVEVA |
Prescription |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
212756 |
002 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
FILM;BUCCAL, SUBLINGUAL |
EQ 12MG BASE;EQ 3MG BASE |
No
|
No
|
2022/06/02
|
2022/06/02
|
AVEVA |
Prescription |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
214737 |
001 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
TABLET;SUBLINGUAL |
EQ 1.4MG BASE;EQ 0.36MG BASE |
No
|
No
|
2023/08/11
(TA)
|
--
|
SUN PHARM INDUSTRIES |
None (Tentative Approval) |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
214737 |
002 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
TABLET;SUBLINGUAL |
EQ 5.7MG BASE;EQ 1.4MG BASE |
No
|
No
|
2023/08/11
(TA)
|
--
|
SUN PHARM INDUSTRIES |
None (Tentative Approval) |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
214737 |
003 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
TABLET;SUBLINGUAL |
EQ 8.6MG BASE;EQ 2.1MG BASE |
No
|
No
|
2023/08/11
(TA)
|
--
|
SUN PHARM INDUSTRIES |
None (Tentative Approval) |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
214737 |
004 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
TABLET;SUBLINGUAL |
EQ 11.4MG BASE;EQ 2.9MG BASE |
No
|
No
|
2023/08/11
(TA)
|
--
|
SUN PHARM INDUSTRIES |
None (Tentative Approval) |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
214737 |
005 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
TABLET;SUBLINGUAL |
EQ 2.9MG BASE;EQ 0.71MG BASE |
No
|
No
|
2023/08/11
(TA)
|
--
|
SUN PHARM INDUSTRIES |
None (Tentative Approval) |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
214737 |
006 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
TABLET;SUBLINGUAL |
EQ 0.7MG BASE;EQ 0.18MG BASE |
No
|
No
|
2023/08/11
(TA)
|
--
|
SUN PHARM INDUSTRIES |
None (Tentative Approval) |