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Generated: May 26, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 016909

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NDA 016909 describes LIDEX, which is a drug marketed by Cnty Line Pharms and is included in four NDAs. It is available from two 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: 016909

Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details

Pharmacology for NDA: 016909

Suppliers and Packaging for NDA: 016909

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OINTMENT;TOPICAL 016909 NDA County Line Pharmaceuticals, LLC 43199-029 43199-029-15 1 TUBE in 1 CARTON (43199-029-15) > 15 g in 1 TUBE
OINTMENT;TOPICAL 016909 NDA County Line Pharmaceuticals, LLC 43199-029 43199-029-30 1 TUBE in 1 CARTON (43199-029-30) > 30 g in 1 TUBE

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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:ABRLD:Yes

Expired Orange Book Patents for NDA: 016909

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cnty Line Pharms
OINTMENT;TOPICAL016909-002Approved Prior to Jan 1, 19824,017,615► Subscribe
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