| 0280-0111-03 |
0280-0111 |
HUMAN OTC DRUG |
Aleve Back and Muscle Pain |
NAPROXEN SODIUM |
TABLET |
ORAL |
20240325 |
N/A |
NDA |
NDA020204 |
Bayer HealthCare LLC. |
NAPROXEN SODIUM |
220 mg/1 |
1 BOTTLE in 1 CARTON (0280-0111-03) / 200 TABLET in 1 BOTTLE |
| 0280-0111-04 |
0280-0111 |
HUMAN OTC DRUG |
Aleve Back and Muscle Pain |
NAPROXEN SODIUM |
TABLET |
ORAL |
20240325 |
N/A |
NDA |
NDA020204 |
Bayer HealthCare LLC. |
NAPROXEN SODIUM |
220 mg/1 |
1 BOTTLE in 1 CARTON (0280-0111-04) / 24 TABLET in 1 BOTTLE |
| 66715-6502-2 |
66715-6502 |
HUMAN OTC DRUG |
Aleve |
Naproxen Sodium |
TABLET |
ORAL |
20220506 |
N/A |
NDA |
NDA020204 |
Lil' Drug Store Products, Inc |
NAPROXEN SODIUM |
220 mg/1 |
2 POUCH in 1 CARTON (66715-6502-2) / 1 TABLET in 1 POUCH |
| 0280-0111-05 |
0280-0111 |
HUMAN OTC DRUG |
Aleve Back and Muscle Pain |
NAPROXEN SODIUM |
TABLET |
ORAL |
20240325 |
N/A |
NDA |
NDA020204 |
Bayer HealthCare LLC. |
NAPROXEN SODIUM |
220 mg/1 |
1 BOTTLE in 1 CARTON (0280-0111-05) / 250 TABLET in 1 BOTTLE |
| 0280-0111-06 |
0280-0111 |
HUMAN OTC DRUG |
Aleve Back and Muscle Pain |
NAPROXEN SODIUM |
TABLET |
ORAL |
20240325 |
N/A |
NDA |
NDA020204 |
Bayer HealthCare LLC. |
NAPROXEN SODIUM |
220 mg/1 |
1 BOTTLE in 1 CARTON (0280-0111-06) / 50 TABLET in 1 BOTTLE |
| 0280-0111-07 |
0280-0111 |
HUMAN OTC DRUG |
Aleve Back and Muscle Pain |
NAPROXEN SODIUM |
TABLET |
ORAL |
20240325 |
N/A |
NDA |
NDA020204 |
Bayer HealthCare LLC. |
NAPROXEN SODIUM |
220 mg/1 |
1 BOTTLE in 1 CARTON (0280-0111-07) / 90 TABLET in 1 BOTTLE |
| 0280-0115-01 |
0280-0115 |
HUMAN OTC DRUG |
Aleve Caplets Soft Grip Arthritis |
NAPROXEN SODIUM |
TABLET |
ORAL |
20240325 |
N/A |
NDA |
NDA020204 |
Bayer HealthCare LLC. |
NAPROXEN SODIUM |
220 mg/1 |
1 BOTTLE in 1 CARTON (0280-0115-01) / 270 TABLET in 1 BOTTLE |
| 0280-0115-02 |
0280-0115 |
HUMAN OTC DRUG |
Aleve Caplets Soft Grip Arthritis |
NAPROXEN SODIUM |
TABLET |
ORAL |
20240325 |
N/A |
NDA |
NDA020204 |
Bayer HealthCare LLC. |
NAPROXEN SODIUM |
220 mg/1 |
1 BOTTLE in 1 CARTON (0280-0115-02) / 50 TABLET in 1 BOTTLE |
| 0280-0115-03 |
0280-0115 |
HUMAN OTC DRUG |
Aleve Caplets Soft Grip Arthritis |
NAPROXEN SODIUM |
TABLET |
ORAL |
20240325 |
N/A |
NDA |
NDA020204 |
Bayer HealthCare LLC. |
NAPROXEN SODIUM |
220 mg/1 |
1 BOTTLE in 1 CARTON (0280-0115-03) / 24 TABLET in 1 BOTTLE |
| 0280-6060-20 |
0280-6060 |
HUMAN OTC DRUG |
Aleve Easy Open Arthritis Cap |
NAPROXEN SODIUM |
TABLET |
ORAL |
20140909 |
N/A |
NDA |
NDA020204 |
Bayer HealthCare LLC. |
NAPROXEN SODIUM |
220 mg/1 |
200 TABLET in 1 BOTTLE (0280-6060-20) |
| 0280-6060-25 |
0280-6060 |
HUMAN OTC DRUG |
Aleve Easy Open Arthritis Cap |
NAPROXEN SODIUM |
TABLET |
ORAL |
20140909 |
N/A |
NDA |
NDA020204 |
Bayer HealthCare LLC. |
NAPROXEN SODIUM |
220 mg/1 |
250 TABLET in 1 BOTTLE (0280-6060-25) |
| 0280-6060-32 |
0280-6060 |
HUMAN OTC DRUG |
Aleve Easy Open Arthritis Cap |
NAPROXEN SODIUM |
TABLET |
ORAL |
20140909 |
N/A |
NDA |
NDA020204 |
Bayer HealthCare LLC. |
NAPROXEN SODIUM |
220 mg/1 |
320 TABLET in 1 BOTTLE (0280-6060-32) |
| 0280-6050-03 |
0280-6050 |
HUMAN OTC DRUG |
Aleve Caplets - Easy Open Arthritis Cap |
NAPROXEN SODIUM |
TABLET |
ORAL |
20131111 |
N/A |
NDA |
NDA020204 |
Bayer HealthCare LLC. |
NAPROXEN SODIUM |
220 mg/1 |
1 BOTTLE in 1 CARTON (0280-6050-03) / 130 TABLET in 1 BOTTLE |
| 0280-6050-04 |
0280-6050 |
HUMAN OTC DRUG |
Aleve Caplets - Easy Open Arthritis Cap |
NAPROXEN SODIUM |
TABLET |
ORAL |
20131111 |
N/A |
NDA |
NDA020204 |
Bayer HealthCare LLC. |
NAPROXEN SODIUM |
220 mg/1 |
1 BOTTLE in 1 CARTON (0280-6050-04) / 150 TABLET in 1 BOTTLE |
| 0280-6050-05 |
0280-6050 |
HUMAN OTC DRUG |
Aleve Caplets - Easy Open Arthritis Cap |
NAPROXEN SODIUM |
TABLET |
ORAL |
20210701 |
N/A |
NDA |
NDA020204 |
Bayer HealthCare LLC. |
NAPROXEN SODIUM |
220 mg/1 |
110 TABLET in 1 BOTTLE (0280-6050-05) |
| 0280-6050-06 |
0280-6050 |
HUMAN OTC DRUG |
Aleve Caplets - Easy Open Arthritis Cap |
NAPROXEN SODIUM |
TABLET |
ORAL |
20210701 |
N/A |
NDA |
NDA020204 |
Bayer HealthCare LLC. |
NAPROXEN SODIUM |
220 mg/1 |
90 TABLET in 1 BOTTLE (0280-6050-06) |
| 0280-6050-27 |
0280-6050 |
HUMAN OTC DRUG |
Aleve Caplets - Easy Open Arthritis Cap |
NAPROXEN SODIUM |
TABLET |
ORAL |
20131111 |
N/A |
NDA |
NDA020204 |
Bayer HealthCare LLC. |
NAPROXEN SODIUM |
220 mg/1 |
1 BOTTLE in 1 CARTON (0280-6050-27) / 270 TABLET in 1 BOTTLE |
| 0280-6050-50 |
0280-6050 |
HUMAN OTC DRUG |
Aleve Caplets - Easy Open Arthritis Cap |
NAPROXEN SODIUM |
TABLET |
ORAL |
20131111 |
N/A |
NDA |
NDA020204 |
Bayer HealthCare LLC. |
NAPROXEN SODIUM |
220 mg/1 |
1 BOTTLE in 1 CARTON (0280-6050-50) / 50 TABLET in 1 BOTTLE |
| 0280-8252-10 |
0280-8252 |
HUMAN OTC DRUG |
Aleve Headache Pain |
NAPROXEN SODIUM |
TABLET |
ORAL |
20240911 |
N/A |
NDA |
NDA020204 |
Bayer HealthCare LLC. |
NAPROXEN SODIUM |
220 mg/1 |
10 TABLET in 1 BOTTLE (0280-8252-10) |
| 0280-8252-24 |
0280-8252 |
HUMAN OTC DRUG |
Aleve Headache Pain |
NAPROXEN SODIUM |
TABLET |
ORAL |
20250424 |
N/A |
NDA |
NDA020204 |
Bayer HealthCare LLC. |
NAPROXEN SODIUM |
220 mg/1 |
1 BOTTLE in 1 CARTON (0280-8252-24) / 24 TABLET in 1 BOTTLE |