| NALOXONE HYDROCHLORIDE |
212455 |
001 |
ANDA |
NALOXONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.4MG/ML |
No
|
No
|
2019/10/15
|
2019/10/15
|
EUGIA PHARMA |
Prescription |
| 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
|
PAR STERILE PRODUCTS |
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 |
| 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 |
| NALOXONE HYDROCHLORIDE |
213279 |
001 |
ANDA |
NALOXONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
1MG/ML |
No
|
No
|
2021/01/14
|
2021/01/14
|
EUGIA PHARMA |
Prescription |
| NALOXONE HYDROCHLORIDE |
214785 |
001 |
ANDA |
NALOXONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.4MG/ML |
No
|
No
|
2021/01/29
|
2021/01/29
|
BAXTER HLTHCARE CORP |
Prescription |
| 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 |
| NALOXONE HYDROCHLORIDE (AUTOINJECTOR) |
215457 |
001 |
NDA |
NALOXONE HYDROCHLORIDE |
SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS |
10MG/0.4ML (10MG/0.4ML) |
Yes
|
No
|
2022/02/28
|
2022/02/28
|
KALEO INC |
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
|
AVEVA |
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
|
AVEVA |
Prescription |
| NALOXONE HYDROCHLORIDE |
213843 |
001 |
ANDA |
NALOXONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
1MG/ML |
No
|
No
|
2022/06/09
|
2022/06/09
|
MYLAN LABS LTD |
Prescription |