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FDA NDA · NDA019796

ELOCON

Sponsor: ORGANON

APPLICATION
NDA019796
TYPE
NDA
ORIGINAL APPROVAL
1989-03-30
LATEST ACTION
2026-07-06
ROUTE
TOPICAL
DOSAGE FORM
LOTION
MARKETING STATUS
Discontinued

Products

ELOCON · ReferenceDiscontinued
MOMETASONE FUROATE 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · LOTION · TOPICAL

Approval history

2026-07-06Labeling · Supplement 30 · standard — Letter ↗AP
2018-05-21Labeling · Supplement 29 · standard — Label ↗AP
2013-03-28Labeling · Supplement 26 · unknown — Label ↗AP
2005-09-09Labeling · Supplement 20 · standard — Letter ↗AP
2002-07-17Efficacy · Supplement 15 · standard — Label ↗AP
2002-07-17Labeling · Supplement 8 · standard — Letter ↗AP
2001-07-13Manufacturing (CMC) · Supplement 14 · standardAP
2000-09-07Manufacturing (CMC) · Supplement 13 · standardAP
1999-05-14Manufacturing (CMC) · Supplement 12 · standardAP
1998-12-28Manufacturing (CMC) · Supplement 11 · standardAP
1998-11-02Manufacturing (CMC) · Supplement 10 · standardAP
1998-06-05Manufacturing (CMC) · Supplement 9 · standardAP
1996-04-16Manufacturing (CMC) · Supplement 7 · standardAP
1996-01-25Manufacturing (CMC) · Supplement 6 · standardAP
1992-03-11Manufacturing (CMC) · Supplement 5 · standardAP
1991-09-25Manufacturing (CMC) · Supplement 4 · standardAP
1989-06-13Manufacturing (CMC) · Supplement 1 · standardAP
1989-03-30Type 3 - New Dosage Form · Original · standardAP
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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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