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Details for New Drug Application (NDA): 018849

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NDA 018849 describes LIDEX, which is a drug marketed by Cnty Line Pharms and is included in four NDAs. It is available from one supplier. Additional details are available on the LIDEX profile page.

The generic ingredient in LIDEX is fluocinonide. There are nine drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the fluocinonide profile page.

Summary for NDA: 018849

Tradename:
LIDEX
Applicant:
Cnty Line Pharms
Ingredient:
fluocinonide
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details

Pharmacology for NDA: 018849

Suppliers and Packaging for NDA: 018849

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LIDEX
fluocinonide
SOLUTION;TOPICAL 018849 NDA County Line Pharmaceuticals, LLC 43199-031 43199-031-20 1 BOTTLE, PLASTIC in 1 CARTON (43199-031-20) > 20 mL in 1 BOTTLE, PLASTIC
LIDEX
fluocinonide
SOLUTION;TOPICAL 018849 NDA County Line Pharmaceuticals, LLC 43199-031 43199-031-60 1 BOTTLE, PLASTIC in 1 CARTON (43199-031-60) > 60 mL in 1 BOTTLE, PLASTIC

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;TOPICALStrength0.05%
Approval Date:Apr 6, 1984TE:ATRLD:No


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