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Generated: November 14, 2018

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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 two suppliers. 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-two 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 019452
Medical Subject Heading (MeSH) Categories for 019452
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 AUTHORIZED GENERIC Seton Pharmaceuticals 13925-506 13925-506-04 1 BOTTLE in 1 CARTON (13925-506-04) > 118.28 mL in 1 BOTTLE
DERMOTIC fluocinolone acetonide OIL/DROPS;OTIC 019452 NDA AUTHORIZED GENERIC Seton Pharmaceuticals 13925-507 13925-507-04 1 BOTTLE in 1 CARTON (13925-507-04) > 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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