| 0135-0508-02 |
0135-0508 |
HUMAN OTC DRUG |
NICORETTE |
nicotine polacrilex |
LOZENGE |
ORAL |
20100301 |
N/A |
NDA |
NDA022360 |
Haleon US Holdings LLC |
NICOTINE |
2 mg/1 |
3 CONTAINER in 1 CARTON (0135-0508-02) / 27 LOZENGE in 1 CONTAINER |
| 0135-0508-03 |
0135-0508 |
HUMAN OTC DRUG |
NICORETTE |
nicotine polacrilex |
LOZENGE |
ORAL |
20100301 |
N/A |
NDA |
NDA022360 |
Haleon US Holdings LLC |
NICOTINE |
2 mg/1 |
5 CONTAINER in 1 CARTON (0135-0508-03) / 27 LOZENGE in 1 CONTAINER |
| 0135-0508-04 |
0135-0508 |
HUMAN OTC DRUG |
NICORETTE |
nicotine polacrilex |
LOZENGE |
ORAL |
20100301 |
N/A |
NDA |
NDA022360 |
Haleon US Holdings LLC |
NICOTINE |
2 mg/1 |
20 LOZENGE in 1 CONTAINER (0135-0508-04) |
| 0135-2800-01 |
0135-2800 |
HUMAN OTC DRUG |
NICORETTE |
nicotine polacrilex |
LOZENGE |
ORAL |
20220601 |
N/A |
NDA |
NDA022360 |
Haleon US Holdings LLC |
NICOTINE |
2 mg/1 |
20 LOZENGE in 1 CONTAINER (0135-2800-01) |
| 0135-2800-02 |
0135-2800 |
HUMAN OTC DRUG |
NICORETTE |
nicotine polacrilex |
LOZENGE |
ORAL |
20220601 |
N/A |
NDA |
NDA022360 |
Haleon US Holdings LLC |
NICOTINE |
2 mg/1 |
3 VIAL in 1 CARTON (0135-2800-02) / 27 LOZENGE in 1 VIAL |
| 0135-8050-20 |
0135-8050 |
HUMAN OTC DRUG |
Nicorette Peppermint |
nicotine polacrilex |
LOZENGE |
ORAL |
20250901 |
N/A |
NDA |
NDA022360 |
Haleon US Holdings LLC |
NICOTINE |
2 mg/1 |
1 VIAL in 1 PACKAGE (0135-8050-20) / 20 LOZENGE in 1 VIAL |
| 0135-8050-81 |
0135-8050 |
HUMAN OTC DRUG |
Nicorette Peppermint |
nicotine polacrilex |
LOZENGE |
ORAL |
20250901 |
N/A |
NDA |
NDA022360 |
Haleon US Holdings LLC |
NICOTINE |
2 mg/1 |
3 VIAL in 1 PACKAGE (0135-8050-81) / 27 LOZENGE in 1 VIAL |
| 0135-8060-20 |
0135-8060 |
HUMAN OTC DRUG |
Nicorette Peppermint |
nicotine polacrilex |
LOZENGE |
ORAL |
20250901 |
N/A |
NDA |
NDA022360 |
Haleon US Holdings LLC |
NICOTINE |
4 mg/1 |
1 VIAL in 1 PACKAGE (0135-8060-20) / 20 LOZENGE in 1 VIAL |
| 0135-8060-81 |
0135-8060 |
HUMAN OTC DRUG |
Nicorette Peppermint |
nicotine polacrilex |
LOZENGE |
ORAL |
20250901 |
N/A |
NDA |
NDA022360 |
Haleon US Holdings LLC |
NICOTINE |
4 mg/1 |
3 VIAL in 1 PACKAGE (0135-8060-81) / 27 LOZENGE in 1 VIAL |
| 0135-1500-01 |
0135-1500 |
HUMAN OTC DRUG |
NICORETTE |
nicotine polacrilex |
LOZENGE |
ORAL |
20220601 |
N/A |
NDA |
NDA022360 |
Haleon US Holdings LLC |
NICOTINE |
4 mg/1 |
20 LOZENGE in 1 CONTAINER (0135-1500-01) |
| 0135-1500-02 |
0135-1500 |
HUMAN OTC DRUG |
NICORETTE |
nicotine polacrilex |
LOZENGE |
ORAL |
20220601 |
N/A |
NDA |
NDA022360 |
Haleon US Holdings LLC |
NICOTINE |
4 mg/1 |
3 VIAL in 1 CARTON (0135-1500-02) / 27 LOZENGE in 1 VIAL |