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Serving 500+ biopharmaceutical companies globally:

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Generated: August 19, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 017373

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NDA 017373 describes LIDEX, which is a drug marketed by Cnty Line Pharms and is included in four NDAs. It is available from three suppliers. 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. Thirty suppliers are listed for this compound. Additional details are available on the fluocinonide profile page.

Summary for NDA: 017373

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details

Pharmacology for NDA: 017373

Suppliers and Packaging for NDA: 017373

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LIDEX
fluocinonide
GEL;TOPICAL 017373 NDA Alvogen Inc. 47781-533 47781-533-26 1 TUBE in 1 CARTON (47781-533-26) > 60 g in 1 TUBE
LIDEX
fluocinonide
GEL;TOPICAL 017373 NDA Alvogen Inc. 47781-533 47781-533-72 1 TUBE in 1 CARTON (47781-533-72) > 15 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:GEL;TOPICALStrength0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes


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Serving 500+ biopharmaceutical companies globally:

Deloitte
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AstraZeneca
Farmers Insurance
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Federal Trade Commission
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US Department of Justice
Boehringer Ingelheim

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