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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 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. Twenty-seven suppliers are listed for this compound. Additional details are available on the fluocinonide profile page.

Summary for NDA: 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

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 54868-6204-0 1 TUBE in 1 CARTON (54868-6204-0) > 60 g in 1 TUBE
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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.1%
Approval Date:Feb 11, 2005TE:ABRLD:Yes
Patent:6,765,001Patent Expiration:Dec 21, 2021Product Flag?YSubstance Flag?Delist Request?
Patent:8,232,264Patent Expiration:Mar 9, 2023Product Flag?YSubstance Flag?Delist Request?
Patent:7,220,424Patent 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


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