| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
207607 |
001 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
FILM;BUCCAL, SUBLINGUAL |
EQ 8MG BASE;EQ 2MG BASE |
No
|
No
|
2018/06/14
|
2018/06/14
|
MYLAN TECHNOLOGIES |
Prescription |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
207607 |
001 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
FILM;BUCCAL, SUBLINGUAL |
EQ 8MG BASE;EQ 2MG BASE |
No
|
No
|
2018/06/14
|
2018/06/14
|
MYLAN TECHNOLOGIES |
Prescription |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
207607 |
002 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
FILM;BUCCAL, SUBLINGUAL |
EQ 12MG BASE;EQ 3MG BASE |
No
|
No
|
2018/06/14
|
2018/06/14
|
MYLAN TECHNOLOGIES |
Prescription |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
207607 |
002 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
FILM;BUCCAL, SUBLINGUAL |
EQ 12MG BASE;EQ 3MG BASE |
No
|
No
|
2018/06/14
|
2018/06/14
|
MYLAN TECHNOLOGIES |
Prescription |
| NALOXONE HYDROCHLORIDE |
207846 |
001 |
ANDA |
NALOXONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.4MG/ML |
No
|
No
|
2018/12/17
|
2018/12/17
|
CHARTWELL RX |
Discontinued |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
205954 |
001 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
FILM;BUCCAL, SUBLINGUAL |
EQ 2MG BASE;EQ 0.5MG BASE |
No
|
No
|
2019/01/24
|
2019/01/24
|
ALVOGEN |
Prescription |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
205954 |
002 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
FILM;BUCCAL, SUBLINGUAL |
EQ 4MG BASE;EQ 1MG BASE |
No
|
No
|
2019/01/24
|
2019/01/24
|
ALVOGEN |
Prescription |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
205954 |
003 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
FILM;BUCCAL, SUBLINGUAL |
EQ 8MG BASE;EQ 2MG BASE |
No
|
No
|
2019/01/24
|
2019/01/24
|
ALVOGEN |
Prescription |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
205954 |
004 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
FILM;BUCCAL, SUBLINGUAL |
EQ 12MG BASE;EQ 3MG BASE |
No
|
No
|
2019/01/24
|
2019/01/24
|
ALVOGEN |
Prescription |
| NALOXONE HYDROCHLORIDE |
209522 |
001 |
ANDA |
NALOXONE HYDROCHLORIDE |
SPRAY, METERED;NASAL |
4MG/SPRAY |
No
|
No
|
2019/04/19
|
2019/04/19
|
TEVA PHARMS USA |
Over-the-counter |
| NALOXONE HYDROCHLORIDE |
212455 |
001 |
ANDA |
NALOXONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.4MG/ML |
No
|
No
|
2019/10/15
|
2019/10/15
|
EUGIA PHARMA |
Discontinued |
| NALOXONE HYDROCHLORIDE |
212456 |
001 |
ANDA |
NALOXONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.4MG/ML |
No
|
No
|
2019/11/04
|
2019/11/04
|
EUGIA PHARMA |
Prescription |
| NALOXONE HYDROCHLORIDE |
211286 |
001 |
ANDA |
NALOXONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.4MG/ML |
No
|
No
|
2020/01/17
|
2020/01/17
|
PH HEALTH |
Discontinued |
| NALOXONE HYDROCHLORIDE |
213209 |
001 |
ANDA |
NALOXONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
1MG/ML |
No
|
No
|
2020/03/16
|
2020/03/16
|
DR REDDYS |
Prescription |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
205601 |
001 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
TABLET;SUBLINGUAL |
EQ 2MG BASE;EQ 0.5MG BASE |
No
|
No
|
2020/03/30
|
2020/03/30
|
RHODES PHARMS |
Prescription |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
205601 |
002 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
TABLET;SUBLINGUAL |
EQ 8MG BASE;EQ 2MG BASE |
No
|
No
|
2020/03/30
|
2020/03/30
|
RHODES PHARMS |
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 |