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Last Updated: April 24, 2024

Details for New Drug Application (NDA): 016909

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NDA 016909 describes LIDEX, which is a drug marketed by Alvogen 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. Twenty-nine suppliers are listed for this compound. Additional details are available on the fluocinonide profile page.

Summary for 016909

Tradename:	LIDEX
Applicant:	Alvogen
Ingredient:	fluocinonide
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 016909

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 016909

Anti-Allergic Agents
Anti-Inflammatory Agents
Glucocorticoids

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	47781-569-73	1 TUBE in 1 CARTON (47781-569-73) / 30 g in 1 TUBE

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	OINTMENT;TOPICAL			Strength	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

Expired US Patents for NDA 016909

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alvogen	LIDEX	fluocinonide	OINTMENT;TOPICAL	016909-002	Approved Prior to Jan 1, 1982	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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