67296-0525-1 |
67296-0525 |
HUMAN PRESCRIPTION DRUG |
Acetaminophen and Codeine Phosphate |
ACETAMINOPHEN and CODEINE PHOSPHATE |
SOLUTION |
ORAL |
19810821 |
N/A |
ANDA |
ANDA087508 |
Redpharm Drug, Inc |
ACETAMINOPHEN; CODEINE PHOSPHATE |
120 mg/5mL; 12 mg/5mL |
118 mL in 1 BOTTLE (67296-0525-1) |
0121-0504-04 |
0121-0504 |
HUMAN PRESCRIPTION DRUG |
Acetaminophen and Codeine Phosphate |
ACETAMINOPHEN and CODEINE PHOSPHATE |
SOLUTION |
ORAL |
19810821 |
20250430 |
ANDA |
ANDA087508 |
PAI Holdings, LLC dba PAI Pharma |
ACETAMINOPHEN; CODEINE PHOSPHATE |
120 mg/5mL; 12 mg/5mL |
118 mL in 1 BOTTLE (0121-0504-04) |
0121-0504-05 |
0121-0504 |
HUMAN PRESCRIPTION DRUG |
Acetaminophen and Codeine Phosphate |
ACETAMINOPHEN and CODEINE PHOSPHATE |
SOLUTION |
ORAL |
20241007 |
20250430 |
ANDA |
ANDA087508 |
PAI Holdings, LLC dba PAI Pharma |
ACETAMINOPHEN; CODEINE PHOSPHATE |
120 mg/5mL; 12 mg/5mL |
5 mL in 1 CUP, UNIT-DOSE (0121-0504-05) |
0121-0504-16 |
0121-0504 |
HUMAN PRESCRIPTION DRUG |
Acetaminophen and Codeine Phosphate |
ACETAMINOPHEN and CODEINE PHOSPHATE |
SOLUTION |
ORAL |
19810821 |
20250430 |
ANDA |
ANDA087508 |
PAI Holdings, LLC dba PAI Pharma |
ACETAMINOPHEN; CODEINE PHOSPHATE |
120 mg/5mL; 12 mg/5mL |
473 mL in 1 BOTTLE (0121-0504-16) |
0121-0504-40 |
0121-0504 |
HUMAN PRESCRIPTION DRUG |
Acetaminophen and Codeine Phosphate |
ACETAMINOPHEN and CODEINE PHOSPHATE |
SOLUTION |
ORAL |
19810821 |
20250430 |
ANDA |
ANDA087508 |
PAI Holdings, LLC dba PAI Pharma |
ACETAMINOPHEN; CODEINE PHOSPHATE |
120 mg/5mL; 12 mg/5mL |
40 TRAY in 1 CASE (0121-0504-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0504-05) |
0121-1008-12 |
0121-1008 |
HUMAN PRESCRIPTION DRUG |
Acetaminophen and Codeine Phosphate |
ACETAMINOPHEN and CODEINE PHOSPHATE |
SOLUTION |
ORAL |
20241007 |
N/A |
ANDA |
ANDA087508 |
PAI Holdings, LLC dba PAI Pharma |
ACETAMINOPHEN; CODEINE PHOSPHATE |
300 mg/12.5mL; 30 mg/12.5mL |
12.5 mL in 1 CUP, UNIT-DOSE (0121-1008-12) |
0121-1008-40 |
0121-1008 |
HUMAN PRESCRIPTION DRUG |
Acetaminophen and Codeine Phosphate |
ACETAMINOPHEN and CODEINE PHOSPHATE |
SOLUTION |
ORAL |
19810821 |
N/A |
ANDA |
ANDA087508 |
PAI Holdings, LLC dba PAI Pharma |
ACETAMINOPHEN; CODEINE PHOSPHATE |
300 mg/12.5mL; 30 mg/12.5mL |
40 TRAY in 1 CASE (0121-1008-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 12.5 mL in 1 CUP, UNIT-DOSE (0121-1008-12) |
63187-291-04 |
63187-291 |
HUMAN PRESCRIPTION DRUG |
Acetaminophen and Codeine Phosphate |
ACETAMINOPHEN and CODEINE PHOSPHATE |
SOLUTION |
ORAL |
20190101 |
N/A |
ANDA |
ANDA087508 |
Proficient Rx LP |
ACETAMINOPHEN; CODEINE PHOSPHATE |
120 mg/5mL; 12 mg/5mL |
118 mL in 1 BOTTLE (63187-291-04) |
53002-3410-1 |
53002-3410 |
HUMAN PRESCRIPTION DRUG |
Acetaminophen and Codeine Phosphate |
ACETAMINOPHEN and CODEINE PHOSPHATE |
SOLUTION |
ORAL |
20181001 |
N/A |
ANDA |
ANDA087508 |
RPK Pharmaceuticals, Inc. |
ACETAMINOPHEN; CODEINE PHOSPHATE |
120 mg/5mL; 12 mg/5mL |
118 mL in 1 BOTTLE (53002-3410-1) |
50090-0215-0 |
50090-0215 |
HUMAN PRESCRIPTION DRUG |
Acetaminophen and Codeine Phosphate |
ACETAMINOPHEN and CODEINE PHOSPHATE |
SOLUTION |
ORAL |
20141128 |
N/A |
ANDA |
ANDA087508 |
A-S Medication Solutions |
ACETAMINOPHEN; CODEINE PHOSPHATE |
120 mg/5mL; 12 mg/5mL |
118 mL in 1 BOTTLE (50090-0215-0) |
64950-374-04 |
64950-374 |
HUMAN PRESCRIPTION DRUG |
Acetaminophen and Codeine Phosphate |
Acetaminophen and Codeine Phosphate |
SOLUTION |
ORAL |
20230810 |
N/A |
ANDA |
ANDA087508 |
Genus Lifesciences Inc. |
ACETAMINOPHEN; CODEINE PHOSPHATE |
120 mg/5mL; 12 mg/5mL |
118 mL in 1 BOTTLE, PLASTIC (64950-374-04) |
64950-374-16 |
64950-374 |
HUMAN PRESCRIPTION DRUG |
Acetaminophen and Codeine Phosphate |
Acetaminophen and Codeine Phosphate |
SOLUTION |
ORAL |
20230810 |
N/A |
ANDA |
ANDA087508 |
Genus Lifesciences Inc. |
ACETAMINOPHEN; CODEINE PHOSPHATE |
120 mg/5mL; 12 mg/5mL |
473 mL in 1 BOTTLE, PLASTIC (64950-374-16) |