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Last Updated: December 12, 2025

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. Twenty-one 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, 2025, www.DrugPatentWatch.com.
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