| 0121-1022-00 |
0121-1022 |
HUMAN OTC DRUG |
Dye Free Childrens Ibuprofen |
Ibuprofen |
SUSPENSION |
ORAL |
20231103 |
N/A |
ANDA |
ANDA210602 |
PAI Holdings, LLC dba PAI Pharma |
IBUPROFEN |
100 mg/5mL |
10 CUP, UNIT-DOSE in 1 CASE (0121-1022-00) / 5 mL in 1 CUP, UNIT-DOSE |
| 0121-1022-05 |
0121-1022 |
HUMAN OTC DRUG |
Dye Free Childrens Ibuprofen |
Ibuprofen |
SUSPENSION |
ORAL |
20231103 |
N/A |
ANDA |
ANDA210602 |
PAI Holdings, LLC dba PAI Pharma |
IBUPROFEN |
100 mg/5mL |
10 CUP, UNIT-DOSE in 1 TRAY (0121-1022-05) / 5 mL in 1 CUP, UNIT-DOSE |
| 0121-2044-00 |
0121-2044 |
HUMAN OTC DRUG |
Dye Free Childrens Ibuprofen |
Ibuprofen |
SUSPENSION |
ORAL |
20231103 |
N/A |
ANDA |
ANDA210602 |
PAI Holdings, LLC dba PAI Pharma |
IBUPROFEN |
200 mg/10mL |
10 CUP, UNIT-DOSE in 1 CASE (0121-2044-00) / 10 mL in 1 CUP, UNIT-DOSE |
| 0121-2044-10 |
0121-2044 |
HUMAN OTC DRUG |
Dye Free Childrens Ibuprofen |
Ibuprofen |
SUSPENSION |
ORAL |
20231103 |
N/A |
ANDA |
ANDA210602 |
PAI Holdings, LLC dba PAI Pharma |
IBUPROFEN |
200 mg/10mL |
10 CUP, UNIT-DOSE in 1 TRAY (0121-2044-10) / 10 mL in 1 CUP, UNIT-DOSE |
| 81522-311-11 |
81522-311 |
HUMAN OTC DRUG |
Childrens Ibuprofen Oral Suspension Dye Free |
IBUPROFEN |
SUSPENSION |
ORAL |
20250905 |
N/A |
ANDA |
ANDA210602 |
FSA Store Inc. (Caring Mill) |
IBUPROFEN |
100 mg/5mL |
1 BOTTLE in 1 CARTON (81522-311-11) / 118 mL in 1 BOTTLE |
| 55758-304-04 |
55758-304 |
HUMAN OTC DRUG |
Dolex Children |
Ibuprofen |
LIQUID |
ORAL |
20200807 |
N/A |
ANDA |
ANDA210602 |
Pharmadel LLC |
IBUPROFEN |
100 mg/100mL |
1 BOTTLE in 1 CARTON (55758-304-04) / 118 mL in 1 BOTTLE |
| 69230-308-11 |
69230-308 |
HUMAN OTC DRUG |
Ibuprofen Oral |
Ibuprofen Oral |
SUSPENSION |
ORAL |
20181123 |
N/A |
ANDA |
ANDA210602 |
Camber Consumer Care Inc |
IBUPROFEN |
100 mg/5mL |
1 BOTTLE in 1 CARTON (69230-308-11) / 118 mL in 1 BOTTLE |
| 69230-309-11 |
69230-309 |
HUMAN OTC DRUG |
Ibuprofen Oral |
Ibuprofen Oral |
SUSPENSION |
ORAL |
20190918 |
N/A |
ANDA |
ANDA210602 |
Camber Consumer Care Inc |
IBUPROFEN |
100 mg/5mL |
1 BOTTLE in 1 CARTON (69230-309-11) / 118 mL in 1 BOTTLE |
| 69230-309-12 |
69230-309 |
HUMAN OTC DRUG |
Ibuprofen Oral |
Ibuprofen Oral |
SUSPENSION |
ORAL |
20190918 |
N/A |
ANDA |
ANDA210602 |
Camber Consumer Care Inc |
IBUPROFEN |
100 mg/5mL |
1 BOTTLE in 1 CARTON (69230-309-12) / 237 mL in 1 BOTTLE |
| 69230-310-11 |
69230-310 |
HUMAN OTC DRUG |
Ibuprofen Oral |
Ibuprofen Oral |
SUSPENSION |
ORAL |
20190918 |
N/A |
ANDA |
ANDA210602 |
Camber Consumer Care Inc |
IBUPROFEN |
100 mg/5mL |
1 BOTTLE in 1 CARTON (69230-310-11) / 118 mL in 1 BOTTLE |
| 69230-310-12 |
69230-310 |
HUMAN OTC DRUG |
Ibuprofen Oral |
Ibuprofen Oral |
SUSPENSION |
ORAL |
20190918 |
N/A |
ANDA |
ANDA210602 |
Camber Consumer Care Inc |
IBUPROFEN |
100 mg/5mL |
1 BOTTLE in 1 CARTON (69230-310-12) / 237 mL in 1 BOTTLE |
| 68071-1628-4 |
68071-1628 |
HUMAN OTC DRUG |
Ibuprofen Oral |
Ibuprofen Oral |
SUSPENSION |
ORAL |
20190319 |
N/A |
ANDA |
ANDA210602 |
NuCare Pharmaceuticals,Inc. |
IBUPROFEN |
100 mg/5mL |
118 mL in 1 BOTTLE (68071-1628-4) |
| 69230-311-12 |
69230-311 |
HUMAN OTC DRUG |
Ibuprofen Oral |
Ibuprofen Oral |
SUSPENSION |
ORAL |
20190918 |
N/A |
ANDA |
ANDA210602 |
Camber Consumer Care Inc |
IBUPROFEN |
100 mg/5mL |
1 BOTTLE in 1 CARTON (69230-311-12) / 237 mL in 1 BOTTLE |
| 69230-311-11 |
69230-311 |
HUMAN OTC DRUG |
Ibuprofen Oral |
Ibuprofen Oral |
SUSPENSION |
ORAL |
20190918 |
N/A |
ANDA |
ANDA210602 |
Camber Consumer Care Inc |
IBUPROFEN |
100 mg/5mL |
1 BOTTLE in 1 CARTON (69230-311-11) / 118 mL in 1 BOTTLE |
| 72162-1911-2 |
72162-1911 |
HUMAN OTC DRUG |
Ibuprofen Oral |
Ibuprofen Oral |
SUSPENSION |
ORAL |
20241224 |
N/A |
ANDA |
ANDA210602 |
Bryant Ranch Prepack |
IBUPROFEN |
100 mg/5mL |
1 BOTTLE in 1 CARTON (72162-1911-2) / 118 mL in 1 BOTTLE |
| 72162-1912-2 |
72162-1912 |
HUMAN OTC DRUG |
Ibuprofen Oral |
Ibuprofen Oral |
SUSPENSION |
ORAL |
20241224 |
N/A |
ANDA |
ANDA210602 |
Bryant Ranch Prepack |
IBUPROFEN |
100 mg/5mL |
1 BOTTLE in 1 CARTON (72162-1912-2) / 118 mL in 1 BOTTLE |
| 52412-910-04 |
52412-910 |
HUMAN OTC DRUG |
Pediacare Childrens Ibuprofen Berry |
IBUPROFEN |
SUSPENSION |
ORAL |
20230103 |
N/A |
ANDA |
ANDA210602 |
RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH |
IBUPROFEN |
100 mg/5mL |
1 BOTTLE in 1 CARTON (52412-910-04) / 118 mL in 1 BOTTLE |
| 72162-1909-2 |
72162-1909 |
HUMAN OTC DRUG |
Ibuprofen Oral |
Ibuprofen Oral |
SUSPENSION |
ORAL |
20250512 |
N/A |
ANDA |
ANDA210602 |
Bryant Ranch Prepack |
IBUPROFEN |
100 mg/5mL |
1 BOTTLE in 1 CARTON (72162-1909-2) / 118 mL in 1 BOTTLE |
| 72162-1910-2 |
72162-1910 |
HUMAN OTC DRUG |
Ibuprofen Oral |
Ibuprofen Oral |
SUSPENSION |
ORAL |
20241224 |
N/A |
ANDA |
ANDA210602 |
Bryant Ranch Prepack |
IBUPROFEN |
100 mg/5mL |
1 BOTTLE in 1 CARTON (72162-1910-2) / 118 mL in 1 BOTTLE |
| 68788-7984-1 |
68788-7984 |
HUMAN OTC DRUG |
Ibuprofen Oral |
Ibuprofen Oral |
SUSPENSION |
ORAL |
20210805 |
N/A |
ANDA |
ANDA210602 |
Preferred Pharmaceuticals Inc. |
IBUPROFEN |
100 mg/5mL |
1 BOTTLE in 1 CARTON (68788-7984-1) / 118 mL in 1 BOTTLE |