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FDA NDA · NDA019452

DERMOTIC

fluocinolone acetonide

Sponsor: HILL DERMAC

APPLICATION
NDA019452
TYPE
NDA
ORIGINAL APPROVAL
1988-02-03
LATEST ACTION
2024-08-30
ROUTE
AURICULAR (OTIC), TOPICAL, OTIC
DOSAGE FORM
OIL, OIL/DROPS
MARKETING STATUS
Prescription

Products

DERMA-SMOOTHE/FS · ReferencePrescription
FLUOCINOLONE ACETONIDE 0.01% · OIL · TOPICAL
DERMA-SMOOTHE/FS · ReferencePrescription
FLUOCINOLONE ACETONIDE 0.01% · OIL · TOPICAL
DERMOTIC · ReferencePrescription
FLUOCINOLONE ACETONIDE 0.01% · OIL/DROPS · OTIC

Approval history

2024-08-30Labeling · Supplement 27 · standard — Label ↗AP
2020-01-29Labeling · Supplement 40 · standard — Letter ↗AP
2016-12-13Manufacturing (CMC) · Supplement 28 · standardAP
2007-12-12Efficacy · Supplement 24 · unknown — Label ↗AP
2007-12-03Manufacturing (CMC) · Supplement 25AP
2005-11-09Labeling · Supplement 16 · standard — Label ↗AP
2005-11-09Efficacy · Supplement 20 · standard — Letter ↗AP
2005-11-09Efficacy · Supplement 19 · standard — Letter ↗AP
2003-04-21Manufacturing (CMC) · Supplement 18 · standard — Label ↗AP
2001-10-10Efficacy · Supplement 17 · standard — Letter ↗AP
1999-08-18Efficacy · Supplement 15 · standard — Letter ↗AP
1997-02-04Manufacturing (CMC) · Supplement 14 · standardAP
1996-08-27Manufacturing (CMC) · Supplement 7 · standardAP
1996-04-26Manufacturing (CMC) · Supplement 13 · standardAP
1996-01-30Manufacturing (CMC) · Supplement 12 · standardAP
1995-02-16Efficacy · Supplement 10 · standardAP
1995-02-16Labeling · Supplement 9 · standardAP
1992-06-25Manufacturing (CMC) · Supplement 8 · standardAP
1990-10-16Manufacturing (CMC) · Supplement 5 · standardAP
1990-01-10Manufacturing (CMC) · Supplement 4 · standardAP
1989-06-27Manufacturing (CMC) · Supplement 3 · standardAP
1989-03-15Manufacturing (CMC) · Supplement 2 · standardAP
1988-09-08Manufacturing (CMC) · Supplement 1 · standardAP
1988-02-03Type 3 - New Dosage Form · Original · standard — Pediatric Medical Review ↗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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