| BUPRENORPHINE HYDROCHLORIDE |
211594 |
007 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE |
FILM;BUCCAL |
EQ 0.9MG BASE |
No
|
No
|
2021/08/03
|
2021/08/03
|
ALVOGEN |
Discontinued |
| BUPRENORPHINE |
210272 |
001 |
ANDA |
BUPRENORPHINE |
FILM, EXTENDED RELEASE;TRANSDERMAL |
5MCG/HR |
No
|
No
|
2021/09/23
|
2021/09/23
|
DIFGEN PHARMS |
Prescription |
| BUPRENORPHINE |
210272 |
002 |
ANDA |
BUPRENORPHINE |
FILM, EXTENDED RELEASE;TRANSDERMAL |
7.5MCG/HR |
No
|
No
|
2021/09/23
|
2021/09/23
|
DIFGEN PHARMS |
Prescription |
| BUPRENORPHINE |
210272 |
003 |
ANDA |
BUPRENORPHINE |
FILM, EXTENDED RELEASE;TRANSDERMAL |
10MCG/HR |
No
|
No
|
2021/09/23
|
2021/09/23
|
DIFGEN PHARMS |
Prescription |
| BUPRENORPHINE |
210272 |
004 |
ANDA |
BUPRENORPHINE |
FILM, EXTENDED RELEASE;TRANSDERMAL |
15MCG/HR |
No
|
No
|
2021/09/23
|
2021/09/23
|
DIFGEN PHARMS |
Prescription |
| BUPRENORPHINE |
210272 |
005 |
ANDA |
BUPRENORPHINE |
FILM, EXTENDED RELEASE;TRANSDERMAL |
20MCG/HR |
No
|
No
|
2021/09/23
|
2021/09/23
|
DIFGEN PHARMS |
Prescription |
| BUPRENORPHINE |
207490 |
001 |
ANDA |
BUPRENORPHINE |
FILM, EXTENDED RELEASE;TRANSDERMAL |
5MCG/HR |
No
|
No
|
2022/05/17
|
2022/05/17
|
ALVOGEN |
Prescription |
| BUPRENORPHINE |
207490 |
002 |
ANDA |
BUPRENORPHINE |
FILM, EXTENDED RELEASE;TRANSDERMAL |
10MCG/HR |
No
|
No
|
2022/05/17
|
2022/05/17
|
ALVOGEN |
Prescription |
| BUPRENORPHINE |
207490 |
003 |
ANDA |
BUPRENORPHINE |
FILM, EXTENDED RELEASE;TRANSDERMAL |
15MCG/HR |
No
|
No
|
2022/05/17
|
2022/05/17
|
ALVOGEN |
Prescription |
| BUPRENORPHINE |
207490 |
004 |
ANDA |
BUPRENORPHINE |
FILM, EXTENDED RELEASE;TRANSDERMAL |
20MCG/HR |
No
|
No
|
2022/05/17
|
2022/05/17
|
ALVOGEN |
Prescription |
| BUPRENORPHINE |
207490 |
005 |
ANDA |
BUPRENORPHINE |
FILM, EXTENDED RELEASE;TRANSDERMAL |
7.5MCG/HR |
No
|
No
|
2022/05/17
|
2023/03/21
|
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
|
DIFGEN PHARMS |
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
|
DIFGEN PHARMS |
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) |