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Generated: January 23, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 015296

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NDA 015296 describes SYNALAR, which is a drug marketed by Medimetriks Pharms and is included in four NDAs. It is available from three suppliers. Additional details are available on the SYNALAR profile page.

The generic ingredient in SYNALAR is fluocinolone acetonide. There are twelve drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the fluocinolone acetonide profile page.
Summary for 015296
Tradename:SYNALAR
Applicant:Medimetriks Pharms
Ingredient:fluocinolone acetonide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 015296
Medical Subject Heading (MeSH) Categories for 015296
Suppliers and Packaging for NDA: 015296
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SYNALAR fluocinolone acetonide SOLUTION;TOPICAL 015296 NDA Medimetriks Pharmaceuticals, Inc. 43538-920 43538-920-60 1 BOTTLE, WITH APPLICATOR in 1 CARTON (43538-920-60) > 60 mL in 1 BOTTLE, WITH APPLICATOR
SYNALAR fluocinolone acetonide SOLUTION;TOPICAL 015296 NDA Medimetriks Pharmaceuticals, Inc. 43538-920 43538-920-90 1 BOTTLE, WITH APPLICATOR in 1 CARTON (43538-920-90) > 90 mL in 1 BOTTLE, WITH APPLICATOR

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;TOPICALStrength0.01%
Approval Date:Approved Prior to Jan 1, 1982TE:ATRLD:Yes

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Daiichi Sankyo
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