| 0121-0833-40 |
0121-0833 |
HUMAN OTC DRUG |
Childrens Ibuprofen Oral Suspension |
Ibuprofen |
SUSPENSION |
ORAL |
20250801 |
N/A |
ANDA |
ANDA214789 |
PAI Holdings, LLC dba PAI Pharma |
IBUPROFEN |
100 mg/5mL |
4 TRAY in 1 CASE (0121-0833-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0833-05) |
| 0121-0833-00 |
0121-0833 |
HUMAN OTC DRUG |
Childrens Ibuprofen Oral Suspension |
Ibuprofen |
SUSPENSION |
ORAL |
20250801 |
N/A |
ANDA |
ANDA214789 |
PAI Holdings, LLC dba PAI Pharma |
IBUPROFEN |
100 mg/5mL |
10 TRAY in 1 CASE (0121-0833-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0833-05) |
| 0121-1666-40 |
0121-1666 |
HUMAN OTC DRUG |
Childrens Ibuprofen Oral Suspension |
Ibuprofen |
SUSPENSION |
ORAL |
20250801 |
N/A |
ANDA |
ANDA214789 |
PAI Holdings, LLC dba PAI Pharma |
IBUPROFEN |
200 mg/10mL |
4 TRAY in 1 CASE (0121-1666-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-1666-10) |
| 0121-1666-00 |
0121-1666 |
HUMAN OTC DRUG |
Childrens Ibuprofen Oral Suspension |
Ibuprofen |
SUSPENSION |
ORAL |
20250801 |
N/A |
ANDA |
ANDA214789 |
PAI Holdings, LLC dba PAI Pharma |
IBUPROFEN |
200 mg/10mL |
10 TRAY in 1 CASE (0121-1666-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-1666-10) |