| 0280-0114-04 |
0280-0114 |
HUMAN OTC DRUG |
Aleve Caplets |
NAPROXEN SODIUM |
TABLET |
ORAL |
20240325 |
N/A |
NDA |
NDA020204 |
Bayer HealthCare LLC. |
NAPROXEN SODIUM |
220 mg/1 |
1 BOTTLE in 1 CARTON (0280-0114-04) / 90 TABLET in 1 BOTTLE |
| 0280-0114-05 |
0280-0114 |
HUMAN OTC DRUG |
Aleve Caplets |
NAPROXEN SODIUM |
TABLET |
ORAL |
20240325 |
N/A |
NDA |
NDA020204 |
Bayer HealthCare LLC. |
NAPROXEN SODIUM |
220 mg/1 |
1 BOTTLE in 1 CARTON (0280-0114-05) / 110 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 |
| 0280-0130-01 |
0280-0130 |
HUMAN OTC DRUG |
Aleve Caplets Easy Open Arthritis |
NAPROXEN SODIUM |
TABLET |
ORAL |
20240325 |
N/A |
NDA |
NDA020204 |
Bayer HealthCare LLC. |
NAPROXEN SODIUM |
220 mg/1 |
90 TABLET in 1 BOTTLE (0280-0130-01) |
| 0280-0130-02 |
0280-0130 |
HUMAN OTC DRUG |
Aleve Caplets Easy Open Arthritis |
NAPROXEN SODIUM |
TABLET |
ORAL |
20240325 |
N/A |
NDA |
NDA020204 |
Bayer HealthCare LLC. |
NAPROXEN SODIUM |
220 mg/1 |
110 TABLET in 1 BOTTLE (0280-0130-02) |
| 0280-0131-01 |
0280-0131 |
HUMAN OTC DRUG |
Aleve Easy Open Arthritis |
NAPROXEN SODIUM |
TABLET |
ORAL |
20240325 |
N/A |
NDA |
NDA020204 |
Bayer HealthCare LLC. |
NAPROXEN SODIUM |
220 mg/1 |
200 TABLET in 1 BOTTLE (0280-0131-01) |
| 0280-0112-02 |
0280-0112 |
HUMAN OTC DRUG |
Aleve Headache Pain |
NAPROXEN SODIUM |
TABLET |
ORAL |
20240325 |
N/A |
NDA |
NDA020204 |
Bayer HealthCare LLC. |
NAPROXEN SODIUM |
220 mg/1 |
1 BOTTLE in 1 CARTON (0280-0112-02) / 24 TABLET in 1 BOTTLE |
| 0280-0112-03 |
0280-0112 |
HUMAN OTC DRUG |
Aleve Headache Pain |
NAPROXEN SODIUM |
TABLET |
ORAL |
20240325 |
N/A |
NDA |
NDA020204 |
Bayer HealthCare LLC. |
NAPROXEN SODIUM |
220 mg/1 |
1 BOTTLE in 1 CARTON (0280-0112-03) / 50 TABLET in 1 BOTTLE |
| 0280-0112-04 |
0280-0112 |
HUMAN OTC DRUG |
Aleve Headache Pain |
NAPROXEN SODIUM |
TABLET |
ORAL |
20240325 |
N/A |
NDA |
NDA020204 |
Bayer HealthCare LLC. |
NAPROXEN SODIUM |
220 mg/1 |
1 BOTTLE in 1 CARTON (0280-0112-04) / 90 TABLET in 1 BOTTLE |
| 0924-6000-00 |
0924-6000 |
HUMAN OTC DRUG |
Bayer Aleve |
Naproxen Sodium |
TABLET |
ORAL |
20230324 |
N/A |
NDA |
NDA020204 |
Acme United Corporation |
NAPROXEN SODIUM |
220 mg/1 |
1 TABLET in 1 POUCH (0924-6000-00) |
| 0924-6000-01 |
0924-6000 |
HUMAN OTC DRUG |
Bayer Aleve |
Naproxen Sodium |
TABLET |
ORAL |
20230324 |
N/A |
NDA |
NDA020204 |
Acme United Corporation |
NAPROXEN SODIUM |
220 mg/1 |
50 POUCH in 1 BOX (0924-6000-01) / 1 TABLET in 1 POUCH |
| 0280-0111-02 |
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 (0280-0111-02) / 110 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 |
| 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 |
| 0280-0111-03 |
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 |
| 66715-5103-0 |
66715-5103 |
HUMAN OTC DRUG |
Aleve |
naproxen sodium tablet |
TABLET |
ORAL |
20061116 |
N/A |
NDA |
NDA020204 |
Lil' Drug Store Products, Inc |
NAPROXEN SODIUM |
220 mg/1 |
30 POUCH in 1 BOX, UNIT-DOSE (66715-5103-0) / 2 TABLET in 1 POUCH |
| 0280-0111-01 |
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 |
10 TABLET in 1 BOTTLE (0280-0111-01) |