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FDA NDA · NDA019543

ELOCON

Sponsor: ORGANON

APPLICATION
NDA019543
TYPE
NDA
ORIGINAL APPROVAL
1987-04-30
LATEST ACTION
2026-07-06
ROUTE
TOPICAL
DOSAGE FORM
OINTMENT
MARKETING STATUS
Discontinued

Products

ELOCON · ReferenceDiscontinued
MOMETASONE FUROATE 0.1% · OINTMENT · TOPICAL

Approval history

2026-07-06Labeling · Supplement 29 · standard — Letter ↗AP
2018-05-21Labeling · Supplement 28 · standard — Label ↗AP
2016-08-05Manufacturing (CMC) · Supplement 27 · standardAP
2013-03-28Labeling · Supplement 24 · unknown — Letter ↗AP
2002-12-15Labeling · Supplement 14 · standard — Letter ↗AP
2002-07-17Efficacy · Supplement 13 · standard — Letter ↗AP
2002-07-17Labeling · Supplement 11 · standard — Letter ↗AP
2002-02-27Manufacturing (CMC) · Supplement 12 · standardAP
2000-01-20Manufacturing (CMC) · Supplement 10 · standardAP
1998-12-28Manufacturing (CMC) · Supplement 8 · standardAP
1998-11-10Manufacturing (CMC) · Supplement 9 · standardAP
1998-06-09Manufacturing (CMC) · Supplement 7 · standardAP
1997-03-07Manufacturing (CMC) · Supplement 6 · standardAP
1996-04-16Manufacturing (CMC) · Supplement 5 · standardAP
1995-10-03Efficacy · Supplement 3AP
1991-09-25Manufacturing (CMC) · Supplement 4 · standardAP
1987-10-29Manufacturing (CMC) · Supplement 1 · standardAP
1987-04-30Type 1 - New Molecular Entity · 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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