← FDA DRUG APPROVALS

FDA NDA · NDA020402

ADVIL LIQUI-GELS

ibuprofen

Sponsor: HALEON US HOLDINGS

APPLICATION
NDA020402
TYPE
NDA
ORIGINAL APPROVAL
1995-04-20
LATEST ACTION
2025-01-08
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Over-the-counter

Products

ADVIL LIQUI-GELS · ReferenceOver-the-counter
IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT · CAPSULE · ORAL
ADVIL MIGRAINE LIQUI-GELS · ReferenceOver-the-counter
IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT · CAPSULE · ORAL

Approval history

2025-01-08Labeling · Supplement 58 · standard — Letter ↗AP
2023-02-23Labeling · Supplement 55 · standard — Letter ↗AP
2022-01-25Labeling · Supplement 53 · standard — Label ↗AP
2018-08-31Labeling · Supplement 47 · standard — Letter ↗AP
2018-08-02Labeling · Supplement 46 · standard — Letter ↗AP
2017-10-18Manufacturing (CMC) · Supplement 44 · standard — Letter ↗AP
2017-08-08Labeling · Supplement 43 · standard — Label ↗AP
2017-03-08Manufacturing (CMC) · Supplement 42 — Label ↗AP
2015-12-17Manufacturing (CMC) · Supplement 40 · standard — Letter ↗AP
2014-09-12Manufacturing (CMC) · Supplement 39 · standardAP
2012-12-11Manufacturing (CMC) · Supplement 37 · standardAP
2012-12-05Manufacturing (CMC) · Supplement 36 · standardAP
2011-04-20Labeling · Supplement 27 · standard — Letter ↗AP
2009-07-09Manufacturing (CMC) · Supplement 26 — Letter ↗AP
2009-05-19Labeling · Supplement 25 · standard — Letter ↗AP
2008-06-11Labeling · Supplement 24 · standard — Letter ↗AP
2006-04-28Labeling · Supplement 16 · standard — Letter ↗AP
2006-02-08Labeling · Supplement 18 · standard — Letter ↗AP
2004-02-26Labeling · Supplement 11 · standard — Letter ↗AP
2001-08-02Manufacturing (CMC) · Supplement 7 · standardAP
2000-03-28Manufacturing (CMC) · Supplement 6 · standardAP
2000-03-16Efficacy · Supplement 5 · standard — Label ↗AP
1999-04-09Manufacturing (CMC) · Supplement 4 · standardAP
1999-02-05Manufacturing (CMC) · Supplement 3 · standardAP
1998-02-23Labeling · Supplement 2 · standardAP
1997-10-06Manufacturing (CMC) · Supplement 1 · standardAP
1995-04-20Type 3 - New Dosage Form · Original · standardAP
VIEW ON DRUGS@FDA ↗

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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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