| 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 |
| 0280-0115-01 |
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) |
| 0280-6000-01 |
0280-6000 |
HUMAN OTC DRUG |
Aleve Caplets |
NAPROXEN SODIUM |
TABLET |
ORAL |
20140226 |
N/A |
NDA |
NDA020204 |
Bayer HealthCare LLC. |
NAPROXEN SODIUM |
220 mg/1 |
24 TABLET in 1 BOTTLE (0280-6000-01) |
| 0280-6000-02 |
0280-6000 |
HUMAN OTC DRUG |
Aleve Caplets |
NAPROXEN SODIUM |
TABLET |
ORAL |
20140326 |
N/A |
NDA |
NDA020204 |
Bayer HealthCare LLC. |
NAPROXEN SODIUM |
220 mg/1 |
1 BOTTLE in 1 CARTON (0280-6000-02) / 200 TABLET in 1 BOTTLE |
| 0280-6000-03 |
0280-6000 |
HUMAN OTC DRUG |
Aleve Caplets |
NAPROXEN SODIUM |
TABLET |
ORAL |
20140226 |
N/A |
NDA |
NDA020204 |
Bayer HealthCare LLC. |
NAPROXEN SODIUM |
220 mg/1 |
1 BOTTLE in 1 CARTON (0280-6000-03) / 130 TABLET in 1 BOTTLE |
| 0280-6000-04 |
0280-6000 |
HUMAN OTC DRUG |
Aleve Caplets |
NAPROXEN SODIUM |
TABLET |
ORAL |
20140226 |
N/A |
NDA |
NDA020204 |
Bayer HealthCare LLC. |
NAPROXEN SODIUM |
220 mg/1 |
1 BOTTLE in 1 CARTON (0280-6000-04) / 225 TABLET in 1 BOTTLE |
| 0280-6000-05 |
0280-6000 |
HUMAN OTC DRUG |
Aleve Caplets |
NAPROXEN SODIUM |
TABLET |
ORAL |
20140226 |
N/A |
NDA |
NDA020204 |
Bayer HealthCare LLC. |
NAPROXEN SODIUM |
220 mg/1 |
1 BOTTLE in 1 CARTON (0280-6000-05) / 36 TABLET in 1 BOTTLE |
| 0280-6000-06 |
0280-6000 |
HUMAN OTC DRUG |
Aleve Caplets |
NAPROXEN SODIUM |
TABLET |
ORAL |
20140226 |
N/A |
NDA |
NDA020204 |
Bayer HealthCare LLC. |
NAPROXEN SODIUM |
220 mg/1 |
1 BLISTER PACK in 1 CARTON (0280-6000-06) / 6 TABLET in 1 BLISTER PACK |
| 0280-6000-07 |
0280-6000 |
HUMAN OTC DRUG |
Aleve Caplets |
NAPROXEN SODIUM |
TABLET |
ORAL |
20140226 |
N/A |
NDA |
NDA020204 |
Bayer HealthCare LLC. |
NAPROXEN SODIUM |
220 mg/1 |
48 TABLET in 1 POUCH (0280-6000-07) |
| 0280-6000-08 |
0280-6000 |
HUMAN OTC DRUG |
Aleve Caplets |
NAPROXEN SODIUM |
TABLET |
ORAL |
20140226 |
N/A |
NDA |
NDA020204 |
Bayer HealthCare LLC. |
NAPROXEN SODIUM |
220 mg/1 |
1 BOTTLE in 1 CARTON (0280-6000-08) / 65 TABLET in 1 BOTTLE |
| 0280-6000-09 |
0280-6000 |
HUMAN OTC DRUG |
Aleve Caplets |
NAPROXEN SODIUM |
TABLET |
ORAL |
20200701 |
N/A |
NDA |
NDA020204 |
Bayer HealthCare LLC. |
NAPROXEN SODIUM |
220 mg/1 |
1 TABLET in 1 POUCH (0280-6000-09) |
| 0280-6000-12 |
0280-6000 |
HUMAN OTC DRUG |
Aleve Caplets |
NAPROXEN SODIUM |
TABLET |
ORAL |
20210701 |
N/A |
NDA |
NDA020204 |
Bayer HealthCare LLC. |
NAPROXEN SODIUM |
220 mg/1 |
1 BOTTLE in 1 CARTON (0280-6000-12) / 90 TABLET in 1 BOTTLE |
| 0280-6000-16 |
0280-6000 |
HUMAN OTC DRUG |
Aleve Caplets |
NAPROXEN SODIUM |
TABLET |
ORAL |
20210701 |
N/A |
NDA |
NDA020204 |
Bayer HealthCare LLC. |
NAPROXEN SODIUM |
220 mg/1 |
1 TABLET in 1 POUCH (0280-6000-16) |
| 0280-6000-24 |
0280-6000 |
HUMAN OTC DRUG |
Aleve Caplets |
NAPROXEN SODIUM |
TABLET |
ORAL |
20140226 |
N/A |
NDA |
NDA020204 |
Bayer HealthCare LLC. |
NAPROXEN SODIUM |
220 mg/1 |
1 BOTTLE in 1 CARTON (0280-6000-24) / 24 TABLET in 1 BOTTLE |