| NALOXONE HYDROCHLORIDE |
212300 |
001 |
ANDA |
NALOXONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
1MG/ML |
No
|
No
|
2022/06/10
|
2022/06/10
|
HIKMA |
Prescription |
| NALOXONE HYDROCHLORIDE |
212300 |
002 |
ANDA |
NALOXONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.4MG/ML |
No
|
No
|
2022/06/10
|
2024/03/07
|
HIKMA |
Prescription |
| NALOXONE HYDROCHLORIDE |
211951 |
001 |
ANDA |
NALOXONE HYDROCHLORIDE |
SPRAY, METERED;NASAL |
4MG/SPRAY |
No
|
No
|
2022/06/21
|
2022/06/21
|
PADAGIS ISRAEL |
Over-the-counter |
| NALOXONE HYDROCHLORIDE |
215964 |
001 |
ANDA |
NALOXONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
1MG/ML |
No
|
No
|
2022/07/29
|
2022/07/29
|
ENDO OPERATIONS |
Prescription |
| NALOXONE HYDROCHLORIDE |
216624 |
001 |
ANDA |
NALOXONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.4MG/ML |
No
|
No
|
2022/10/26
|
2022/10/26
|
ACCORD HLTHCARE |
Prescription |
| NALOXONE HYDROCHLORIDE |
216624 |
002 |
ANDA |
NALOXONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
1MG/ML |
No
|
No
|
2022/10/26
|
2022/10/26
|
ACCORD HLTHCARE |
Prescription |
| NALOXONE HYDROCHLORIDE |
214792 |
001 |
ANDA |
NALOXONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.4MG/ML |
No
|
No
|
2022/11/07
|
2022/11/07
|
BAXTER HLTHCARE CORP |
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) |
| NALOXONE HYDROCHLORIDE |
216977 |
001 |
ANDA |
NALOXONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
1MG/ML |
No
|
No
|
2023/10/06
|
2023/10/06
|
BPI LABS |
Prescription |
| NALOXONE HYDROCHLORIDE |
218404 |
001 |
ANDA |
NALOXONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.4MG/ML |
No
|
No
|
2024/02/29
|
2024/02/29
|
MANKIND PHARMA |
Prescription |
| NALOXONE HYDROCHLORIDE |
213573 |
001 |
ANDA |
NALOXONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.4MG/ML |
No
|
No
|
2024/04/02
|
2024/04/02
|
FRESENIUS KABI USA |
Prescription |
| NALOXONE HYDROCHLORIDE |
213573 |
002 |
ANDA |
NALOXONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
1MG/ML |
No
|
No
|
2024/04/02
|
2024/04/02
|
FRESENIUS KABI USA |
Prescription |
| NALOXONE HYDROCHLORIDE |
217992 |
001 |
ANDA |
NALOXONE HYDROCHLORIDE |
SPRAY, METERED;NASAL |
4MG/SPRAY |
No
|
No
|
2024/04/23
|
2024/04/23
|
AMNEAL |
Over-the-counter |