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FDA NDA · NDA020941

ABREVA

docosanol

Sponsor: HALEON US HOLDINGS

APPLICATION
NDA020941
TYPE
NDA
ORIGINAL APPROVAL
2000-07-25
LATEST ACTION
2026-04-14
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Over-the-counter

Products

ABREVA · ReferenceOver-the-counter
DOCOSANOL 10% · CREAM · TOPICAL

Approval history

2026-04-14Labeling · Supplement 17 · standard — Letter ↗AP
2017-01-10Labeling · Supplement 12 · standard — Letter ↗AP
2015-01-30Labeling · Supplement 11 · standard — Label ↗AP
2008-02-08Manufacturing (CMC) · Supplement 9 — Letter ↗AP
2007-05-23Manufacturing (CMC) · Supplement 6 — Letter ↗AP
2002-12-13Manufacturing (CMC) · Supplement 3 · standardAP
2001-09-18Manufacturing (CMC) · Supplement 2 · standardAP
2001-03-12Manufacturing (CMC) · Supplement 1 · standardAP
2000-07-25Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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