| 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) |
| 0280-6010-10 |
0280-6010 |
HUMAN OTC DRUG |
Aleve |
NAPROXEN SODIUM |
TABLET |
ORAL |
20020726 |
N/A |
NDA |
NDA020204 |
Bayer HealthCare LLC. |
NAPROXEN SODIUM |
220 mg/1 |
1 BOTTLE in 1 TRAY (0280-6010-10) / 10 TABLET in 1 BOTTLE |
| 0280-6010-24 |
0280-6010 |
HUMAN OTC DRUG |
Aleve |
NAPROXEN SODIUM |
TABLET |
ORAL |
20020726 |
N/A |
NDA |
NDA020204 |
Bayer HealthCare LLC. |
NAPROXEN SODIUM |
220 mg/1 |
1 BOTTLE in 1 CARTON (0280-6010-24) / 24 TABLET in 1 BOTTLE |
| 0280-6010-50 |
0280-6010 |
HUMAN OTC DRUG |
Aleve |
NAPROXEN SODIUM |
TABLET |
ORAL |
20020726 |
N/A |
NDA |
NDA020204 |
Bayer HealthCare LLC. |
NAPROXEN SODIUM |
220 mg/1 |
1 BOTTLE in 1 CARTON (0280-6010-50) / 50 TABLET in 1 BOTTLE |
| 0280-6070-40 |
0280-6070 |
HUMAN OTC DRUG |
Aleve Gelcaps |
NAPROXEN SODIUM |
TABLET, COATED |
ORAL |
20020801 |
N/A |
NDA |
NDA020204 |
Bayer HealthCare LLC. |
NAPROXEN SODIUM |
220 mg/1 |
1 BOTTLE in 1 CARTON (0280-6070-40) / 40 TABLET, COATED in 1 BOTTLE |
| 29485-7534-3 |
29485-7534 |
HUMAN OTC DRUG |
Aleve |
Naproxen sodium tablet |
TABLET |
ORAL |
20161101 |
20251231 |
NDA |
NDA020204 |
Lil' Drug Store Products, Inc. |
NAPROXEN SODIUM |
200 mg/1 |
30 POUCH in 1 BOX (29485-7534-3) / 1 TABLET in 1 POUCH |
| 47682-488-50 |
47682-488 |
HUMAN OTC DRUG |
Bayer Aleve |
Naproxen Sodium |
TABLET |
ORAL |
20140124 |
N/A |
NDA |
NDA020204 |
Unifirst First Aid Corporation |
NAPROXEN SODIUM |
220 mg/1 |
50 POUCH in 1 BOX (47682-488-50) / 1 TABLET in 1 POUCH |
| 70264-011-01 |
70264-011 |
HUMAN OTC DRUG |
Aleve |
NAPROXEN SODIUM |
TABLET |
ORAL |
20140226 |
N/A |
NDA |
NDA020204 |
R J General Corporation |
NAPROXEN SODIUM |
220 mg/1 |
50 POUCH in 1 CARTON (70264-011-01) / 1 TABLET in 1 POUCH |
| 0280-6050-01 |
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 |
100 TABLET in 1 BOTTLE (0280-6050-01) |
| 0280-6050-02 |
0280-6050 |
HUMAN OTC DRUG |
Aleve Caplets - Easy Open Arthritis Cap |
NAPROXEN SODIUM |
TABLET |
ORAL |
20200611 |
N/A |
NDA |
NDA020204 |
Bayer HealthCare LLC. |
NAPROXEN SODIUM |
220 mg/1 |
24 TABLET in 1 BOTTLE (0280-6050-02) |
| 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 |