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Last Updated: November 12, 2024

Details for New Drug Application (NDA): 016908


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NDA 016908 describes LIDEX-E, which is a drug marketed by Alvogen and is included in one NDA. Additional details are available on the LIDEX-E profile page.

The generic ingredient in LIDEX-E 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 016908
Tradename:LIDEX-E
Applicant:Alvogen
Ingredient:fluocinonide
Patents:0
Medical Subject Heading (MeSH) Categories for 016908

Profile for product number 002

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**Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

Profile for product number 003

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**Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

Expired US Patents for NDA 016908

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Alvogen LIDEX fluocinonide CREAM;TOPICAL 016908-002 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
Alvogen LIDEX fluocinonide CREAM;TOPICAL 016908-002 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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