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Last Updated: April 19, 2024

Details for New Drug Application (NDA): 021758

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NDA 021758 describes VANOS, which is a drug marketed by Bausch and is included in one NDA. It is available from one supplier. Additional details are available on the VANOS profile page.

The generic ingredient in VANOS 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 021758

Tradename:	VANOS
Applicant:	Bausch
Ingredient:	fluocinonide
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 021758

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 021758

Anti-Allergic Agents
Anti-Inflammatory Agents
Glucocorticoids

Suppliers and Packaging for NDA: 021758

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VANOS	fluocinonide	CREAM;TOPICAL	021758	NDA	Bausch Health US, LLC	99207-525	99207-525-10	1 TUBE in 1 CARTON (99207-525-10) / 120 g in 1 TUBE
VANOS	fluocinonide	CREAM;TOPICAL	021758	NDA	Bausch Health US, LLC	99207-525	99207-525-30	1 TUBE in 1 CARTON (99207-525-30) / 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	0.1%
Approval Date:	Feb 11, 2005	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021758

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	VANOS	fluocinonide	CREAM;TOPICAL	021758-001	Feb 11, 2005	⤷ Try a Trial	⤷ Try a Trial
Bausch	VANOS	fluocinonide	CREAM;TOPICAL	021758-001	Feb 11, 2005	⤷ Try a Trial	⤷ Try a Trial
Bausch	VANOS	fluocinonide	CREAM;TOPICAL	021758-001	Feb 11, 2005	⤷ Try a Trial	⤷ Try a Trial
Bausch	VANOS	fluocinonide	CREAM;TOPICAL	021758-001	Feb 11, 2005	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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