FDA NDA · NDA020802

EXCEDRIN MIGRAINE GELTABS

acetaminophen, asprin, caffeine

Sponsor: HALEON US HOLDINGS

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APPLICATION
NDA020802
TYPE
NDA
ORIGINAL APPROVAL
1998-01-14
LATEST ACTION
2026-10-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter

Products

EXCEDRIN (MIGRAINE RELIEF) · ReferenceOver-the-counter
ACETAMINOPHEN 250MG, ASPIRIN 250MG, CAFFEINE 65MG · TABLET · ORAL

Approval history

2026-10-02Labeling · Supplement 46 · standard — Letter ↗AP
2023-05-15Manufacturing (CMC) · Supplement 42 — Letter ↗AP
2023-04-17Labeling · Supplement 43 · standard — Label ↗AP
2021-12-07Manufacturing (CMC) · Supplement 40 — Letter ↗AP
2021-11-03Labeling · Supplement 38 · standard — Letter ↗AP
2020-02-27Labeling · Supplement 34 · standard — Label ↗AP
2019-04-15Labeling · Supplement 33 · standard — Letter ↗AP
2018-01-02Labeling · Supplement 32 · standard — Label ↗AP
2017-10-12Labeling · Supplement 31 · standard — Letter ↗AP
2017-09-13Manufacturing (CMC) · Supplement 30 · standardAP
2016-04-29Manufacturing (CMC) · Supplement 28 · standardAP
2016-01-28Manufacturing (CMC) · Supplement 27 · standardAP
2015-11-17Manufacturing (CMC) · Supplement 26 · standardAP
2014-07-30Manufacturing (CMC) · Supplement 25 · standardAP
2014-07-15Labeling · Supplement 24 · standard — Label ↗AP
2014-04-15Labeling · Supplement 22 · standard — Label ↗AP
2010-02-04Labeling · Supplement 19 · standard — Letter ↗AP
2007-01-31Labeling · Supplement 15 · standard — Letter ↗AP
2004-08-27Manufacturing (CMC) · Supplement 10 · standard — Letter ↗AP
2003-05-21Labeling · Supplement 9 · standard — Label ↗AP
2002-04-19Manufacturing (CMC) · Supplement 7 · standardAP
2000-10-10Manufacturing (CMC) · Supplement 6 · standardAP
2000-09-07Labeling · Supplement 4 · standardAP
2000-04-26Manufacturing (CMC) · Supplement 5 · standardAP
1999-10-07Efficacy · Supplement 2 · standard — Letter ↗AP
1999-08-20Manufacturing (CMC) · Supplement 3 · standardAP
1998-10-22Manufacturing (CMC) · Supplement 1 · standardAP
1998-01-14Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

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