← FDA DRUG APPROVALS

FDA NDA · NDA021140

IMODIUM MULTI-SYMPTOM RELIEF

loperamide hydrochloride and dimethicone

Sponsor: KENVUE BRANDS

APPLICATION
NDA021140
TYPE
NDA
ORIGINAL APPROVAL
2000-11-30
LATEST ACTION
2026-03-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter

Products

IMODIUM MULTI-SYMPTOM RELIEF · ReferenceOver-the-counter
LOPERAMIDE HYDROCHLORIDE 2MG, SIMETHICONE 125MG · TABLET · ORAL

Approval history

2026-03-02Manufacturing (CMC) · Supplement 39 — Letter ↗AP
2018-12-11Labeling · Supplement 26 · standard — Label ↗AP
2017-04-12Labeling · Supplement 25 · standard — Label ↗AP
2015-12-02Manufacturing (CMC) · Supplement 24 · standardAP
2015-09-01Manufacturing (CMC) · Supplement 23 · standardAP
2015-08-07Manufacturing (CMC) · Supplement 19 · standardAP
2015-08-03Manufacturing (CMC) · Supplement 22 · standardAP
2015-03-18Labeling · Supplement 20 · standard — Label ↗AP
2015-02-03Manufacturing (CMC) · Supplement 21 · standardAP
2012-05-03Labeling · Supplement 16 · standard — Letter ↗AP
2008-04-30Efficacy · Supplement 11 · unknown — Summary Review ↗AP
2008-02-05Labeling · Supplement 13 · standard — Letter ↗AP
2007-09-14Manufacturing (CMC) · Supplement 12 — Label ↗AP
2004-06-16Labeling · Supplement 3 · standard — Letter ↗AP
2003-01-27Labeling · Supplement 2 · standard — Label ↗AP
2001-09-12Manufacturing (CMC) · Supplement 1 · standardAP
2000-11-30Type 3 - New Dosage Form · Original · standard — Label ↗AP
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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