| 0536-5895-88 |
0536-5895 |
HUMAN OTC DRUG |
Nicotine |
Nicotine |
PATCH |
TRANSDERMAL |
20240625 |
N/A |
ANDA |
ANDA074612 |
Rugby Laboratories |
NICOTINE |
14 mg/24h |
14 POUCH in 1 CARTON (0536-5895-88) / 1 h in 1 POUCH |
| 0536-5896-53 |
0536-5896 |
HUMAN OTC DRUG |
Nicotine |
Nicotine |
PATCH |
TRANSDERMAL |
20240625 |
N/A |
ANDA |
ANDA074612 |
Rugby Laboratories |
NICOTINE |
21 mg/24h |
7 POUCH in 1 CARTON (0536-5896-53) / 1 h in 1 POUCH |
| 0536-5896-71 |
0536-5896 |
HUMAN OTC DRUG |
Nicotine |
Nicotine |
PATCH |
TRANSDERMAL |
20240625 |
N/A |
ANDA |
ANDA074612 |
Rugby Laboratories |
NICOTINE |
21 mg/24h |
28 POUCH in 1 CARTON (0536-5896-71) / 1 h in 1 POUCH |
| 0536-5896-88 |
0536-5896 |
HUMAN OTC DRUG |
Nicotine |
Nicotine |
PATCH |
TRANSDERMAL |
20240625 |
N/A |
ANDA |
ANDA074612 |
Rugby Laboratories |
NICOTINE |
21 mg/24h |
14 POUCH in 1 CARTON (0536-5896-88) / 1 h in 1 POUCH |
| 53329-192-89 |
53329-192 |
HUMAN OTC DRUG |
Medline |
nicotine |
PATCH |
TRANSDERMAL |
20220828 |
N/A |
ANDA |
ANDA074612 |
Medline Industries, LP |
NICOTINE |
21 mg/1 |
14 POUCH in 1 CARTON (53329-192-89) / 1 PATCH in 1 POUCH (53329-192-09) |
| 76282-781-40 |
76282-781 |
HUMAN OTC DRUG |
Nicotine Transdermal System |
Nicotine |
FILM, EXTENDED RELEASE |
TRANSDERMAL |
20251013 |
N/A |
ANDA |
ANDA074612 |
EXELAN PHARMACEUTICALS, INC. |
NICOTINE |
7 mg/24h |
14 POUCH in 1 CARTON (76282-781-40) / 1 h in 1 POUCH |
| 76282-782-40 |
76282-782 |
HUMAN OTC DRUG |
Nicotine Transdermal System |
Nicotine |
FILM, EXTENDED RELEASE |
TRANSDERMAL |
20251013 |
N/A |
ANDA |
ANDA074612 |
EXELAN PHARMACEUTICALS, INC. |
NICOTINE |
14 mg/24h |
14 POUCH in 1 CARTON (76282-782-40) / 1 h in 1 POUCH |
| 76282-783-40 |
76282-783 |
HUMAN OTC DRUG |
Nicotine Transdermal System |
Nicotine |
FILM, EXTENDED RELEASE |
TRANSDERMAL |
20251013 |
N/A |
ANDA |
ANDA074612 |
EXELAN PHARMACEUTICALS, INC. |
NICOTINE |
21 mg/24h |
14 POUCH in 1 CARTON (76282-783-40) / 1 h in 1 POUCH |
| 3215-0120-14 |
3215-0120 |
HUMAN OTC DRUG |
Nicotine Transdermal System |
Nicotine Transdermal System |
PATCH |
TRANSDERMAL |
20251124 |
N/A |
ANDA |
ANDA074612 |
Aveva Drug Delivery Systems, Inc. |
NICOTINE |
7 mg/24h |
14 PATCH in 1 CARTON (3215-0120-14) / 1 h in 1 PATCH |
| 3215-0121-14 |
3215-0121 |
HUMAN OTC DRUG |
Nicotine Transdermal System |
Nicotine Transdermal System |
PATCH |
TRANSDERMAL |
20251124 |
N/A |
ANDA |
ANDA074612 |
Aveva Drug Delivery Systems, Inc. |
NICOTINE |
14 mg/24h |
14 PATCH in 1 CARTON (3215-0121-14) / 1 h in 1 PATCH |
| 3215-0122-14 |
3215-0122 |
HUMAN OTC DRUG |
Nicotine Transdermal System |
Nicotine Transdermal System |
PATCH |
TRANSDERMAL |
20251124 |
N/A |
ANDA |
ANDA074612 |
Aveva Drug Delivery Systems, Inc. |
NICOTINE |
21 mg/24h |
14 PATCH in 1 CARTON (3215-0122-14) / 1 h in 1 PATCH |
| 3215-1201-07 |
3215-1201 |
HUMAN OTC DRUG |
Nicotine Transdermal System |
Nicotine Transdermal System |
PATCH |
TRANSDERMAL |
20240625 |
N/A |
ANDA |
ANDA074612 |
Aveva Drug Delivery Systems Inc. |
NICOTINE |
7 mg/24h |
7 PATCH in 1 CARTON (3215-1201-07) / 24 h in 1 PATCH |
| 3215-1201-14 |
3215-1201 |
HUMAN OTC DRUG |
Nicotine Transdermal System |
Nicotine Transdermal System |
PATCH |
TRANSDERMAL |
20240625 |
N/A |
ANDA |
ANDA074612 |
Aveva Drug Delivery Systems Inc. |
NICOTINE |
7 mg/24h |
14 PATCH in 1 CARTON (3215-1201-14) / 24 h in 1 PATCH |
| 3215-1202-07 |
3215-1202 |
HUMAN OTC DRUG |
Nicotine Transdermal System |
Nicotine Transdermal System |
PATCH |
TRANSDERMAL |
20240625 |
N/A |
ANDA |
ANDA074612 |
Aveva Drug Delivery Systems Inc. |
NICOTINE |
14 mg/24h |
7 POUCH in 1 CARTON (3215-1202-07) / 24 h in 1 POUCH |
| 3215-1202-14 |
3215-1202 |
HUMAN OTC DRUG |
Nicotine Transdermal System |
Nicotine Transdermal System |
PATCH |
TRANSDERMAL |
20240625 |
N/A |
ANDA |
ANDA074612 |
Aveva Drug Delivery Systems Inc. |
NICOTINE |
14 mg/24h |
14 POUCH in 1 CARTON (3215-1202-14) / 24 h in 1 POUCH |
| 3215-1202-28 |
3215-1202 |
HUMAN OTC DRUG |
Nicotine Transdermal System |
Nicotine Transdermal System |
PATCH |
TRANSDERMAL |
20240625 |
N/A |
ANDA |
ANDA074612 |
Aveva Drug Delivery Systems Inc. |
NICOTINE |
14 mg/24h |
28 POUCH in 1 CARTON (3215-1202-28) / 24 h in 1 POUCH |
| 3215-1203-07 |
3215-1203 |
HUMAN OTC DRUG |
Nicotine Transdermal System |
Nicotine Transdermal System |
PATCH |
TRANSDERMAL |
20240625 |
N/A |
ANDA |
ANDA074612 |
Aveva Drug Delivery Systems Inc. |
NICOTINE |
21 mg/24h |
7 POUCH in 1 CARTON (3215-1203-07) / 24 h in 1 POUCH |
| 3215-1203-14 |
3215-1203 |
HUMAN OTC DRUG |
Nicotine Transdermal System |
Nicotine Transdermal System |
PATCH |
TRANSDERMAL |
20240625 |
N/A |
ANDA |
ANDA074612 |
Aveva Drug Delivery Systems Inc. |
NICOTINE |
21 mg/24h |
14 POUCH in 1 CARTON (3215-1203-14) / 24 h in 1 POUCH |
| 3215-1203-28 |
3215-1203 |
HUMAN OTC DRUG |
Nicotine Transdermal System |
Nicotine Transdermal System |
PATCH |
TRANSDERMAL |
20240625 |
N/A |
ANDA |
ANDA074612 |
Aveva Drug Delivery Systems Inc. |
NICOTINE |
21 mg/24h |
28 POUCH in 1 CARTON (3215-1203-28) / 24 h in 1 POUCH |
| 70677-0030-1 |
70677-0030 |
HUMAN OTC DRUG |
Nicotine |
Nicotine |
PATCH |
TRANSDERMAL |
20171204 |
20260731 |
ANDA |
ANDA074612 |
Strategic Sourcing Services LLC |
NICOTINE |
7 mg/24h |
14 POUCH in 1 CARTON (70677-0030-1) / 1 h in 1 POUCH |