| 0121-1019-30 |
0121-1019 |
HUMAN PRESCRIPTION DRUG |
buprenorphine hydrochloride |
buprenorphine hydrochloride |
TABLET |
SUBLINGUAL |
20231012 |
N/A |
ANDA |
ANDA090622 |
PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma |
BUPRENORPHINE HYDROCHLORIDE |
2 mg/1 |
30 TABLET in 1 BOTTLE (0121-1019-30) |
| 0121-2038-30 |
0121-2038 |
HUMAN PRESCRIPTION DRUG |
buprenorphine hydrochloride |
buprenorphine hydrochloride |
TABLET |
SUBLINGUAL |
20231012 |
N/A |
ANDA |
ANDA090622 |
PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma |
BUPRENORPHINE HYDROCHLORIDE |
8 mg/1 |
30 TABLET in 1 BOTTLE (0121-2038-30) |
| 70518-4571-0 |
70518-4571 |
HUMAN PRESCRIPTION DRUG |
buprenorphine hydrochloride |
buprenorphine hydrochloride |
TABLET |
SUBLINGUAL |
20260210 |
N/A |
ANDA |
ANDA090622 |
REMEDYREPACK INC. |
BUPRENORPHINE HYDROCHLORIDE |
8 mg/1 |
30 POUCH in 1 BOX (70518-4571-0) / 1 TABLET in 1 POUCH (70518-4571-1) |
| 50090-7559-0 |
50090-7559 |
HUMAN PRESCRIPTION DRUG |
buprenorphine hydrochloride |
buprenorphine hydrochloride |
TABLET |
SUBLINGUAL |
20250527 |
N/A |
ANDA |
ANDA090622 |
A-S Medication Solutions |
BUPRENORPHINE HYDROCHLORIDE |
8 mg/1 |
30 TABLET in 1 BOTTLE (50090-7559-0) |