BUPRENORPHINE |
211586 |
005 |
ANDA |
BUPRENORPHINE |
FILM, EXTENDED RELEASE;TRANSDERMAL |
20MCG/HR |
No
|
No
|
2020/04/14
|
2020/04/14
|
AMNEAL |
Prescription |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
211785 |
001 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
FILM;BUCCAL, SUBLINGUAL |
EQ 2MG BASE;EQ 0.5MG BASE |
No
|
No
|
2020/04/17
|
2020/04/17
|
MYLAN TECHNOLOGIES |
Prescription |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
211785 |
002 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
FILM;BUCCAL, SUBLINGUAL |
EQ 4MG BASE;EQ 1MG BASE |
No
|
No
|
2020/04/17
|
2020/04/17
|
MYLAN TECHNOLOGIES |
Prescription |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
206953 |
001 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
TABLET;SUBLINGUAL |
EQ 2MG BASE;EQ 0.5MG BASE |
No
|
No
|
2020/07/17
|
2020/07/17
|
DR REDDYS LABS SA |
Discontinued |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
206953 |
002 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
TABLET;SUBLINGUAL |
EQ 8MG BASE;EQ 2MG BASE |
No
|
No
|
2020/07/17
|
2020/07/17
|
DR REDDYS LABS SA |
Discontinued |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
209069 |
001 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
TABLET;SUBLINGUAL |
EQ 2MG BASE;EQ 0.5MG BASE |
No
|
No
|
2020/07/17
|
2020/07/17
|
WES PHARMA INC |
Prescription |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
209069 |
002 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
TABLET;SUBLINGUAL |
EQ 8MG BASE;EQ 2MG BASE |
No
|
No
|
2020/07/17
|
2020/07/17
|
WES PHARMA INC |
Prescription |
BUPRENORPHINE |
210162 |
001 |
ANDA |
BUPRENORPHINE |
FILM, EXTENDED RELEASE;TRANSDERMAL |
5MCG/HR |
No
|
No
|
2021/05/03
|
2021/05/03
|
MYLAN TECH VIATRIS |
Discontinued |
BUPRENORPHINE |
210162 |
002 |
ANDA |
BUPRENORPHINE |
FILM, EXTENDED RELEASE;TRANSDERMAL |
7.5MCG/HR |
No
|
No
|
2021/05/03
|
2021/05/03
|
MYLAN TECH VIATRIS |
Discontinued |
BUPRENORPHINE |
210162 |
003 |
ANDA |
BUPRENORPHINE |
FILM, EXTENDED RELEASE;TRANSDERMAL |
10MCG/HR |
No
|
No
|
2021/05/03
|
2021/05/03
|
MYLAN TECH VIATRIS |
Discontinued |
BUPRENORPHINE |
210162 |
004 |
ANDA |
BUPRENORPHINE |
FILM, EXTENDED RELEASE;TRANSDERMAL |
15MCG/HR |
No
|
No
|
2021/05/03
|
2021/05/03
|
MYLAN TECH VIATRIS |
Discontinued |
BUPRENORPHINE |
210162 |
005 |
ANDA |
BUPRENORPHINE |
FILM, EXTENDED RELEASE;TRANSDERMAL |
20MCG/HR |
No
|
No
|
2021/05/03
|
2021/05/03
|
MYLAN TECH VIATRIS |
Discontinued |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
214930 |
001 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
TABLET;SUBLINGUAL |
EQ 2MG BASE;EQ 0.5MG BASE |
No
|
No
|
2021/06/15
|
2021/06/15
|
ALKEM LABS LTD |
Prescription |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
214930 |
002 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
TABLET;SUBLINGUAL |
EQ 8MG BASE;EQ 2MG BASE |
No
|
No
|
2021/06/15
|
2021/06/15
|
ALKEM LABS LTD |
Prescription |
BUPRENORPHINE HYDROCHLORIDE |
211594 |
001 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE |
FILM;BUCCAL |
EQ 0.075MG BASE |
No
|
No
|
2021/08/03
|
2021/08/03
|
ALVOGEN |
Discontinued |
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 |