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Last Updated: June 22, 2021

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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 three 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-four suppliers are listed for this compound. Additional details are available on the fluocinonide profile page.
Summary for 016909
Applicant:Cnty Line Pharms
Formulation / Manufacturing:see details
Pharmacology for NDA: 016909
Medical Subject Heading (MeSH) Categories for 016909
Suppliers and Packaging for NDA: 016909
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LIDEX fluocinonide OINTMENT;TOPICAL 016909 NDA Alvogen Inc. 47781-569 47781-569-26 1 TUBE in 1 CARTON (47781-569-26) > 60 g in 1 TUBE
LIDEX fluocinonide OINTMENT;TOPICAL 016909 NDA Alvogen Inc. 47781-569 47781-569-72 1 TUBE in 1 CARTON (47781-569-72) > 15 g in 1 TUBE
Paragraph IV (Patent) Challenges for 016909
Tradename Dosage Ingredient NDA Submissiondate
LIDEX OINTMENT;TOPICAL fluocinonide 016909

Profile 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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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

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