| 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 |
| 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 |
| 0280-0114-08 |
0280-0114 |
HUMAN OTC DRUG |
Aleve Caplets |
NAPROXEN SODIUM |
TABLET |
ORAL |
20240325 |
N/A |
NDA |
NDA020204 |
Bayer HealthCare LLC. |
NAPROXEN SODIUM |
220 mg/1 |
270 TABLET in 1 BOTTLE (0280-0114-08) |
| 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) |
| 0280-0113-01 |
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) |
| 0280-6050-01 |
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) |
| 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 |
| 66715-6402-8 |
66715-6402 |
HUMAN OTC DRUG |
Aleve |
Naproxen Sodium |
TABLET |
ORAL |
20220419 |
N/A |
NDA |
NDA020204 |
Lil' Drug Store Products, Inc |
NAPROXEN SODIUM |
220 mg/1 |
30 POUCH in 1 BOX, UNIT-DOSE (66715-6402-8) / 1 TABLET in 1 POUCH |
| 67751-144-03 |
67751-144 |
HUMAN OTC DRUG |
Aleve |
naproxen sodium |
TABLET |
ORAL |
20171204 |
N/A |
NDA |
NDA020204 |
Navajo Manufacturing Company Inc |
NAPROXEN SODIUM |
220 mg/1 |
1 POUCH in 1 CARTON (67751-144-03) / 1 TABLET in 1 POUCH |
| 67751-144-04 |
67751-144 |
HUMAN OTC DRUG |
Aleve |
naproxen sodium |
TABLET |
ORAL |
20171204 |
N/A |
NDA |
NDA020204 |
Navajo Manufacturing Company Inc |
NAPROXEN SODIUM |
220 mg/1 |
2 POUCH in 1 CARTON (67751-144-04) / 1 TABLET in 1 POUCH |