| NALOXONE HYDROCHLORIDE |
217992 |
001 |
ANDA |
NALOXONE HYDROCHLORIDE |
SPRAY, METERED;NASAL |
4MG/SPRAY |
No
|
No
|
2024/04/23
|
2024/04/23
|
AMNEAL |
Over-the-counter |
| NALOXONE HYDROCHLORIDE |
216719 |
001 |
ANDA |
NALOXONE HYDROCHLORIDE |
SPRAY;NASAL |
8MG/SPRAY |
No
|
No
|
2025/04/24
|
2025/04/24
|
PADAGIS ISRAEL |
Discontinued |
| NALOXONE HYDROCHLORIDE |
214211 |
001 |
ANDA |
NALOXONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.4MG/ML |
No
|
No
|
2025/08/21
|
2025/08/21
|
STERINOVA INC |
Prescription |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
219727 |
001 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
TABLET;SUBLINGUAL |
EQ 2MG BASE;EQ 0.5MG BASE |
No
|
No
|
2025/12/15
|
2025/12/15
|
ASCENT PHARMS INC |
Prescription |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
219727 |
002 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
TABLET;SUBLINGUAL |
EQ 8MG BASE;EQ 2MG BASE |
No
|
No
|
2025/12/15
|
2025/12/15
|
ASCENT PHARMS INC |
Prescription |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
219850 |
001 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
FILM;BUCCAL, SUBLINGUAL |
EQ 2MG BASE;EQ 0.5MG BASE |
No
|
No
|
2026/01/21
|
--
|
ASCENT PHARMS INC |
Prescription |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
219850 |
002 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
FILM;BUCCAL, SUBLINGUAL |
EQ 4MG BASE;EQ 1MG BASE |
No
|
No
|
2026/01/21
|
--
|
ASCENT PHARMS INC |
Prescription |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
219850 |
003 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
FILM;BUCCAL, SUBLINGUAL |
EQ 8MG BASE;EQ 2MG BASE |
No
|
No
|
2026/01/21
|
--
|
ASCENT PHARMS INC |
Prescription |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
219850 |
004 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
FILM;BUCCAL, SUBLINGUAL |
EQ 12MG BASE;EQ 3MG BASE |
No
|
No
|
2026/01/21
|
--
|
ASCENT PHARMS INC |
Prescription |