| 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 |
| 70000-0510-1 |
70000-0510 |
HUMAN OTC DRUG |
Nicotine Transdermal System |
Nicotine Transdermal System |
PATCH, EXTENDED RELEASE |
TRANSDERMAL |
20240901 |
N/A |
ANDA |
ANDA074612 |
Cardinal Health |
NICOTINE |
7 mg/24h |
7 POUCH in 1 CARTON (70000-0510-1) / 1 h in 1 POUCH |
| 70000-0510-2 |
70000-0510 |
HUMAN OTC DRUG |
Nicotine Transdermal System |
Nicotine Transdermal System |
PATCH, EXTENDED RELEASE |
TRANSDERMAL |
20240901 |
N/A |
ANDA |
ANDA074612 |
Cardinal Health |
NICOTINE |
7 mg/24h |
14 POUCH in 1 CARTON (70000-0510-2) / 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 |
| 50742-669-07 |
50742-669 |
HUMAN OTC DRUG |
Nicotine Transdermal System |
Nicotine Transdermal System |
PATCH |
TRANSDERMAL |
20260519 |
N/A |
ANDA |
ANDA074612 |
Ingenus Pharmaceuticals, LLC |
NICOTINE |
14 mg/24h |
7 POUCH in 1 CARTON (50742-669-07) / 24 h in 1 POUCH |
| 50742-669-14 |
50742-669 |
HUMAN OTC DRUG |
Nicotine Transdermal System |
Nicotine Transdermal System |
PATCH |
TRANSDERMAL |
20260519 |
N/A |
ANDA |
ANDA074612 |
Ingenus Pharmaceuticals, LLC |
NICOTINE |
14 mg/24h |
14 POUCH in 1 CARTON (50742-669-14) / 24 h in 1 POUCH |
| 50742-669-28 |
50742-669 |
HUMAN OTC DRUG |
Nicotine Transdermal System |
Nicotine Transdermal System |
PATCH |
TRANSDERMAL |
20260519 |
N/A |
ANDA |
ANDA074612 |
Ingenus Pharmaceuticals, LLC |
NICOTINE |
14 mg/24h |
28 POUCH in 1 CARTON (50742-669-28) / 24 h in 1 POUCH |
| 68001-432-88 |
68001-432 |
HUMAN OTC DRUG |
Nicotine Transdermal System |
Nicotine Transdermal System |
PATCH, EXTENDED RELEASE |
TRANSDERMAL |
20240627 |
N/A |
ANDA |
ANDA074612 |
BluePoint Laboratories |
NICOTINE |
7 mg/24h |
7 POUCH in 1 CARTON (68001-432-88) / 1 h in 1 POUCH |
| 68001-432-90 |
68001-432 |
HUMAN OTC DRUG |
Nicotine Transdermal System |
Nicotine Transdermal System |
PATCH, EXTENDED RELEASE |
TRANSDERMAL |
20240627 |
N/A |
ANDA |
ANDA074612 |
BluePoint Laboratories |
NICOTINE |
7 mg/24h |
14 POUCH in 1 CARTON (68001-432-90) / 1 h in 1 POUCH |
| 0536-5894-53 |
0536-5894 |
HUMAN OTC DRUG |
Nicotine |
Nicotine |
PATCH |
TRANSDERMAL |
20240625 |
N/A |
ANDA |
ANDA074612 |
Rugby Laboratories |
NICOTINE |
7 mg/24h |
7 POUCH in 1 CARTON (0536-5894-53) / 1 h in 1 POUCH |
| 0536-5894-88 |
0536-5894 |
HUMAN OTC DRUG |
Nicotine |
Nicotine |
PATCH |
TRANSDERMAL |
20240625 |
N/A |
ANDA |
ANDA074612 |
Rugby Laboratories |
NICOTINE |
7 mg/24h |
14 POUCH in 1 CARTON (0536-5894-88) / 1 h in 1 POUCH |
| 70000-0511-1 |
70000-0511 |
HUMAN OTC DRUG |
Nicotine Transdermal System |
Nicotine Transdermal System |
PATCH, EXTENDED RELEASE |
TRANSDERMAL |
20240901 |
N/A |
ANDA |
ANDA074612 |
Cardinal Health |
NICOTINE |
14 mg/24h |
7 POUCH in 1 CARTON (70000-0511-1) / 1 h in 1 POUCH |
| 70000-0511-2 |
70000-0511 |
HUMAN OTC DRUG |
Nicotine Transdermal System |
Nicotine Transdermal System |
PATCH, EXTENDED RELEASE |
TRANSDERMAL |
20240901 |
N/A |
ANDA |
ANDA074612 |
Cardinal Health |
NICOTINE |
14 mg/24h |
14 POUCH in 1 CARTON (70000-0511-2) / 1 h in 1 POUCH |
| 46122-568-03 |
46122-568 |
HUMAN OTC DRUG |
Nicotine Transdermal System |
Nicotine Transdermal System |
PATCH, EXTENDED RELEASE |
TRANSDERMAL |
20240625 |
N/A |
ANDA |
ANDA074612 |
AmerisourceBergen Drug Corporation |
NICOTINE |
21 mg/24h |
28 POUCH in 1 CARTON (46122-568-03) / 1 h in 1 POUCH |
| 46122-568-07 |
46122-568 |
HUMAN OTC DRUG |
Nicotine Transdermal System |
Nicotine Transdermal System |
PATCH, EXTENDED RELEASE |
TRANSDERMAL |
20240625 |
N/A |
ANDA |
ANDA074612 |
AmerisourceBergen Drug Corporation |
NICOTINE |
21 mg/24h |
7 POUCH in 1 CARTON (46122-568-07) / 1 h in 1 POUCH |
| 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 |
| 50742-670-07 |
50742-670 |
HUMAN OTC DRUG |
Nicotine Transdermal System |
Nicotine Transdermal System |
PATCH |
TRANSDERMAL |
20260519 |
N/A |
ANDA |
ANDA074612 |
Ingenus Pharmaceuticals, LLC |
NICOTINE |
21 mg/24h |
7 POUCH in 1 CARTON (50742-670-07) / 24 h in 1 POUCH |
| 50742-670-14 |
50742-670 |
HUMAN OTC DRUG |
Nicotine Transdermal System |
Nicotine Transdermal System |
PATCH |
TRANSDERMAL |
20260519 |
N/A |
ANDA |
ANDA074612 |
Ingenus Pharmaceuticals, LLC |
NICOTINE |
21 mg/24h |
14 POUCH in 1 CARTON (50742-670-14) / 24 h in 1 POUCH |
| 50742-670-28 |
50742-670 |
HUMAN OTC DRUG |
Nicotine Transdermal System |
Nicotine Transdermal System |
PATCH |
TRANSDERMAL |
20260519 |
N/A |
ANDA |
ANDA074612 |
Ingenus Pharmaceuticals, LLC |
NICOTINE |
21 mg/24h |
28 POUCH in 1 CARTON (50742-670-28) / 24 h in 1 POUCH |
| 68001-433-88 |
68001-433 |
HUMAN OTC DRUG |
Nicotine Transdermal System |
Nicotine Transdermal System |
PATCH, EXTENDED RELEASE |
TRANSDERMAL |
20240627 |
N/A |
ANDA |
ANDA074612 |
BluePoint Laboratories |
NICOTINE |
14 mg/24h |
7 POUCH in 1 CARTON (68001-433-88) / 1 h in 1 POUCH |