0121-1018-30 |
0121-1018 |
HUMAN PRESCRIPTION DRUG |
Buprenorphine and Naloxone |
buprenorphine hydrochloride and naloxone hydrochloride |
TABLET |
SUBLINGUAL |
20230905 |
N/A |
ANDA |
ANDA204431 |
PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
2 mg/1; .5 mg/1 |
30 TABLET in 1 BOTTLE, PLASTIC (0121-1018-30) |
0121-2036-30 |
0121-2036 |
HUMAN PRESCRIPTION DRUG |
Buprenorphine and Naloxone |
buprenorphine hydrochloride and naloxone hydrochloride |
TABLET |
SUBLINGUAL |
20230905 |
N/A |
ANDA |
ANDA204431 |
PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
8 mg/1; 2 mg/1 |
30 TABLET in 1 BOTTLE, PLASTIC (0121-2036-30) |
50383-287-93 |
50383-287 |
HUMAN PRESCRIPTION DRUG |
Buprenorphine and Naloxone |
buprenorphine hydrochloride and naloxone hydrochloride |
TABLET |
SUBLINGUAL |
20160107 |
20250331 |
ANDA |
ANDA204431 |
Akorn Operating Company LLC (dba Akorn) |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
8 mg/1; 2 mg/1 |
30 TABLET in 1 BOTTLE, PLASTIC (50383-287-93) |
50383-294-93 |
50383-294 |
HUMAN PRESCRIPTION DRUG |
Buprenorphine and Naloxone |
buprenorphine hydrochloride and naloxone hydrochloride |
TABLET |
SUBLINGUAL |
20160107 |
20250331 |
ANDA |
ANDA204431 |
Akorn Operating Company LLC (dba Akorn) |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
2 mg/1; .5 mg/1 |
30 TABLET in 1 BOTTLE, PLASTIC (50383-294-93) |