← FDA DRUG APPROVALS

FDA NDA · NDA020204

ALEVE CAPLETS

naproxen sodium

Sponsor: BAYER

APPLICATION
NDA020204
TYPE
NDA
ORIGINAL APPROVAL
1994-01-11
LATEST ACTION
2026-03-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter

Products

ALEVE · ReferenceOver-the-counter
NAPROXEN SODIUM 220MG · TABLET · ORAL

Approval history

2026-03-10Labeling · Supplement 90 · standard — Letter ↗AP
2025-04-24Labeling · Supplement 89 · standard — Letter ↗AP
2024-09-11Labeling · Supplement 88 · standard — Letter ↗AP
2023-04-04Manufacturing (CMC) · Supplement 84 — Letter ↗AP
2022-03-10Labeling · Supplement 83 · standard — Letter ↗AP
2021-04-01Labeling · Supplement 81 · standard — Letter ↗AP
2020-12-31Labeling · Supplement 78 · standard — Letter ↗AP
2020-12-31Labeling · Supplement 80 · standard — Letter ↗AP
2020-12-31Labeling · Supplement 79 · standard — Letter ↗AP
2020-12-31Labeling · Supplement 77 · standard — Letter ↗AP
2020-10-28Labeling · Supplement 76 · standard — Letter ↗AP
2020-05-08Labeling · Supplement 72 · standard — Label ↗AP
2020-04-23Labeling · Supplement 71 · standard — Label ↗AP
2020-03-02Labeling · Supplement 70 · standard — Letter ↗AP
2019-08-07Labeling · Supplement 68 · standard — Letter ↗AP
2019-07-23Labeling · Supplement 67 · standard — Letter ↗AP
2019-07-02Labeling · Supplement 66 · standard — Letter ↗AP
2019-05-13Labeling · Supplement 64 · standard — Label ↗AP
2019-05-13Labeling · Supplement 65 · standardAP
2019-05-13Labeling · Supplement 63 · standard — Letter ↗AP
2019-01-28Labeling · Supplement 61 · standard — Label ↗AP
2019-01-03Labeling · Supplement 62 · standard — Label ↗AP
2018-09-21Labeling · Supplement 59 · standard — Letter ↗AP
2018-08-28Labeling · Supplement 58 · standard — Letter ↗AP
2018-07-25Labeling · Supplement 57 · standard — Letter ↗AP
2018-06-11Labeling · Supplement 56 · standard — Letter ↗AP
2018-06-08Labeling · Supplement 55 · standard — Letter ↗AP
2018-03-29Labeling · Supplement 54 · standard — Letter ↗AP
2018-03-27Labeling · Supplement 53 · standard — Label ↗AP
2017-09-14Labeling · Supplement 52 · standard — Letter ↗AP
2017-08-22Labeling · Supplement 51 · standard — Label ↗AP
2016-07-28Manufacturing (CMC) · Supplement 49 · standardAP
2016-02-25Manufacturing (CMC) · Supplement 48 · standard — Label ↗AP
2015-02-04Manufacturing (CMC) · Supplement 46 · standardAP
2013-04-18Labeling · Supplement 44 · standard — Letter ↗AP
2013-02-07Labeling · Supplement 38 · standard — Letter ↗AP
2013-01-07Manufacturing (CMC) · Supplement 43 · standardAP
2013-01-03Manufacturing (CMC) · Supplement 42 · standard — Letter ↗AP
2012-11-13Manufacturing (CMC) · Supplement 41 · standardAP
2012-03-16Labeling · Supplement 40 · standard — Letter ↗AP
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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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