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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 019452


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NDA 019452 describes DERMA-SMOOTHE/FS, which is a drug marketed by Hill Dermac and is included in one NDA. It is available from one supplier. Additional details are available on the DERMA-SMOOTHE/FS profile page.

The generic ingredient in DERMA-SMOOTHE/FS is fluocinolone acetonide. There are twelve drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the fluocinolone acetonide profile page.
Summary for 019452
Tradename:DERMA-SMOOTHE/FS
Applicant:Hill Dermac
Ingredient:fluocinolone acetonide
Patents:0
Pharmacology for NDA: 019452
Mechanism of ActionCorticosteroid Hormone Receptor Agonists
Medical Subject Heading (MeSH) Categories for 019452
Anti-Inflammatory Agents
Glucocorticoids
Suppliers and Packaging for NDA: 019452
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DERMOTIC fluocinolone acetonide OIL/DROPS;OTIC 019452 NDA Royal Pharmaceuticals 68791-101 68791-101-01 1 BOTTLE in 1 CARTON (68791-101-01) / 20 mL in 1 BOTTLE
DERMOTIC fluocinolone acetonide OIL/DROPS;OTIC 019452 NDA Royal Pharmaceuticals 68791-101 68791-101-04 1 BOTTLE in 1 CARTON (68791-101-04) / 118.28 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:OIL;TOPICALStrength0.01%
Approval Date:Feb 3, 1988TE:ATRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:OIL;TOPICALStrength0.01%
Approval Date:Nov 9, 2005TE:ATRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:OIL/DROPS;OTICStrength0.01%
Approval Date:Nov 9, 2005TE:ATRLD:Yes

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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