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FDA NDA · NDA018849

LIDEX

Sponsor: ALVOGEN

APPLICATION
NDA018849
TYPE
NDA
ORIGINAL APPROVAL
1984-04-06
LATEST ACTION
2014-02-28
ROUTE
TOPICAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

LIDEX · ReferenceDiscontinued
FLUOCINONIDE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · TOPICAL

Approval history

2014-02-28Manufacturing (CMC) · Supplement 20 — Letter ↗AP
2005-12-16Manufacturing (CMC) · Supplement 18 · standard — Letter ↗AP
2001-09-27Manufacturing (CMC) · Supplement 16 · standardAP
2000-10-27Manufacturing (CMC) · Supplement 15 · standardAP
1996-07-22Manufacturing (CMC) · Supplement 14 · standardAP
1995-03-14Labeling · Supplement 10AP
1995-03-01Labeling · Supplement 13 · standardAP
1992-11-16Manufacturing (CMC) · Supplement 12 · standardAP
1992-04-24Manufacturing (CMC) · Supplement 11 · standardAP
1990-02-13Manufacturing (CMC) · Supplement 9 · standardAP
1989-12-19Manufacturing (CMC) · Supplement 7 · standardAP
1989-12-19Manufacturing (CMC) · Supplement 5 · standardAP
1989-12-06Manufacturing (CMC) · Supplement 8 · standardAP
1989-02-10Manufacturing (CMC) · Supplement 4 · standardAP
1985-04-09Manufacturing (CMC) · Supplement 1 · standardAP
1985-02-13Labeling · Supplement 2AP
1985-01-29Manufacturing (CMC) · Supplement 3 · standardAP
1984-04-06Type 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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