| 0280-0041-01 |
0280-0041 |
HUMAN OTC DRUG |
Aleve Headache Pain |
Naproxen Sodium |
TABLET |
ORAL |
20210601 |
N/A |
NDA |
NDA020204 |
Bayer HealthCare LLC |
NAPROXEN SODIUM |
220 mg/1 |
1 BOTTLE in 1 CARTON (0280-0041-01) / 175 TABLET in 1 BOTTLE |
| 0280-0041-02 |
0280-0041 |
HUMAN OTC DRUG |
Aleve Headache Pain |
Naproxen Sodium |
TABLET |
ORAL |
20210601 |
N/A |
NDA |
NDA020204 |
Bayer HealthCare LLC |
NAPROXEN SODIUM |
220 mg/1 |
1 BOTTLE in 1 CARTON (0280-0041-02) / 50 TABLET in 1 BOTTLE |
| 0280-0041-03 |
0280-0041 |
HUMAN OTC DRUG |
Aleve Headache Pain |
Naproxen Sodium |
TABLET |
ORAL |
20210601 |
N/A |
NDA |
NDA020204 |
Bayer HealthCare LLC |
NAPROXEN SODIUM |
220 mg/1 |
1 BOTTLE in 1 CARTON (0280-0041-03) / 90 TABLET in 1 BOTTLE |
| 0280-0041-04 |
0280-0041 |
HUMAN OTC DRUG |
Aleve Headache Pain |
Naproxen Sodium |
TABLET |
ORAL |
20210601 |
N/A |
NDA |
NDA020204 |
Bayer HealthCare LLC |
NAPROXEN SODIUM |
220 mg/1 |
1 BOTTLE in 1 CARTON (0280-0041-04) / 24 TABLET in 1 BOTTLE |
| 0280-0041-05 |
0280-0041 |
HUMAN OTC DRUG |
Aleve Headache Pain |
Naproxen Sodium |
TABLET |
ORAL |
20210601 |
N/A |
NDA |
NDA020204 |
Bayer HealthCare LLC |
NAPROXEN SODIUM |
220 mg/1 |
1 TABLET in 1 POUCH (0280-0041-05) |
| 0280-0114-01 |
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 (0280-0114-01) / 200 TABLET in 1 BOTTLE |
| 0280-0114-02 |
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 (0280-0114-02) / 24 TABLET in 1 BOTTLE |
| 0280-0114-03 |
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 (0280-0114-03) / 50 TABLET in 1 BOTTLE |
| 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 |
| 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 |
| 0280-0113-01 |
0280-0113 |
HUMAN OTC DRUG |
Aleve |
NAPROXEN SODIUM |
TABLET |
ORAL |
20240325 |
N/A |
NDA |
NDA020204 |
Bayer HealthCare LLC. |
NAPROXEN SODIUM |
220 mg/1 |
10 TABLET in 1 BOTTLE (0280-0113-01) |
| 0280-0113-02 |
0280-0113 |
HUMAN OTC DRUG |
Aleve |
NAPROXEN SODIUM |
TABLET |
ORAL |
20240404 |
N/A |
NDA |
NDA020204 |
Bayer HealthCare LLC. |
NAPROXEN SODIUM |
220 mg/1 |
1 BOTTLE in 1 CARTON (0280-0113-02) / 24 TABLET in 1 BOTTLE |
| 0280-0113-03 |
0280-0113 |
HUMAN OTC DRUG |
Aleve |
NAPROXEN SODIUM |
TABLET |
ORAL |
20240404 |
N/A |
NDA |
NDA020204 |
Bayer HealthCare LLC. |
NAPROXEN SODIUM |
220 mg/1 |
1 BOTTLE in 1 CARTON (0280-0113-03) / 270 TABLET in 1 BOTTLE |
| 0280-0113-04 |
0280-0113 |
HUMAN OTC DRUG |
Aleve |
NAPROXEN SODIUM |
TABLET |
ORAL |
20240404 |
N/A |
NDA |
NDA020204 |
Bayer HealthCare LLC. |
NAPROXEN SODIUM |
220 mg/1 |
1 BOTTLE in 1 CARTON (0280-0113-04) / 50 TABLET in 1 BOTTLE |
| 0280-0113-05 |
0280-0113 |
HUMAN OTC DRUG |
Aleve |
NAPROXEN SODIUM |
TABLET |
ORAL |
20240404 |
N/A |
NDA |
NDA020204 |
Bayer HealthCare LLC. |
NAPROXEN SODIUM |
220 mg/1 |
1 BOTTLE in 1 CARTON (0280-0113-05) / 90 TABLET in 1 BOTTLE |
| 0280-0113-06 |
0280-0113 |
HUMAN OTC DRUG |
Aleve |
NAPROXEN SODIUM |
TABLET |
ORAL |
20240404 |
N/A |
NDA |
NDA020204 |
Bayer HealthCare LLC. |
NAPROXEN SODIUM |
220 mg/1 |
1 BOTTLE in 1 CARTON (0280-0113-06) / 110 TABLET in 1 BOTTLE |
| 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) |
| 0280-0111-01 |
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) |
| 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 |