← FDA DRUG APPROVALS

FDA NDA · NDA021307

LOTRIMIN ULTRA ATHLETES FOOT

butenafine hydrochloride

Sponsor: BAYER HEALTHCARE LLC

APPLICATION
NDA021307
TYPE
NDA
ORIGINAL APPROVAL
2001-12-07
LATEST ACTION
2024-07-10
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Over-the-counter

Products

LOTRIMIN ULTRA · ReferenceOver-the-counter
BUTENAFINE HYDROCHLORIDE 1% · CREAM · TOPICAL

Approval history

2024-07-10Labeling · Supplement 24 · standard — Label ↗AP
2024-04-19Labeling · Supplement 23 · standard — Letter ↗AP
2024-01-02Labeling · Supplement 22 · standard — Label ↗AP
2023-08-29Labeling · Supplement 21 · standard — Letter ↗AP
2021-10-18Labeling · Supplement 19 · standard — Letter ↗AP
2020-12-15Manufacturing (CMC) · Supplement 18 — Letter ↗AP
2017-01-19Manufacturing (CMC) · Supplement 16 · standardAP
2015-12-18Labeling · Supplement 15 · standard — Letter ↗AP
2014-12-17Efficacy · Supplement 14 · standard — Letter ↗AP
2012-05-02Labeling · Supplement 13 · standard — Letter ↗AP
2011-03-31Labeling · Supplement 12 · standard — Letter ↗AP
2006-04-03Labeling · Supplement 4 · standard — Letter ↗AP
2001-12-07Type 8 - Partial Rx to OTC Switch · Original · standard — Letter ↗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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