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Generated: November 12, 2018

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Details for New Drug Application (NDA): 021758

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NDA 021758 describes VANOS, which is a drug marketed by Medicis and is included in one NDA. It is available from two suppliers. There are four patents protecting this drug and one Paragraph IV challenge. 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. Thirty-eight suppliers are listed for this compound. Additional details are available on the fluocinonide profile page.
Summary for 021758
Tradename:VANOS
Applicant:Medicis
Ingredient:fluocinonide
Patents:4
Formulation / Manufacturing:see details
Pharmacology for NDA: 021758
Medical Subject Heading (MeSH) Categories for 021758
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 AUTHORIZED GENERIC Oceanside Pharmaceuticals 68682-992 68682-992-10 1 TUBE in 1 CARTON (68682-992-10) > 120 g in 1 TUBE
VANOS fluocinonide CREAM;TOPICAL 021758 NDA AUTHORIZED GENERIC Oceanside Pharmaceuticals 68682-992 68682-992-30 1 TUBE in 1 CARTON (68682-992-30) > 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.1%
Approval Date:Feb 11, 2005TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:Dec 21, 2021Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Jan 7, 2023Product Flag?Substance Flag?Delist Request?
Patented Use:RELIEF OF THE INFLAMMATORY AND PRURITIC MANIFESTATIONS OF CORTICOSTEROID RESPONSIVE DERMATOSES IN PATIENTS 12 YEARS OF AGE OR OLDER
Patent:➤ Sign UpPatent Expiration:Sep 11, 2022Product Flag?Substance Flag?Delist Request?
Patented Use:RELIEF OF THE INFLAMMATORY AND PRURITIC MANIFESTATIONS OF CORTICOSTEROID RESPONSIVE DERMATOSES IN PATIENTS 12 YEARS OF AGE OR OLDER

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