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Generated: July 15, 2018

DrugPatentWatch Database Preview

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 three 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-four 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
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
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 Physicians Total Care, Inc. 54868-6204 E 54868-6204-0
VANOS fluocinonide CREAM;TOPICAL 021758 NDA AUTHORIZED GENERIC Oceanside Pharmaceuticals 68682-992 N 68682-992-10

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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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
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Mallinckrodt
Boehringer Ingelheim
Cantor Fitzgerald
Dow
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Julphar
Queensland Health

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