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Last Updated: February 9, 2023

Details for New Drug Application (NDA): 022204


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NDA 022204 describes GELNIQUE, which is a drug marketed by Allergan and is included in two NDAs. It is available from one supplier. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the GELNIQUE profile page.

The generic ingredient in GELNIQUE is oxybutynin. There are sixteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the oxybutynin profile page.
Summary for 022204
Tradename:GELNIQUE
Applicant:Allergan
Ingredient:oxybutynin chloride
Patents:3
Formulation / Manufacturing:see details
Pharmacology for NDA: 022204
Suppliers and Packaging for NDA: 022204
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GELNIQUE oxybutynin chloride GEL;TRANSDERMAL 022204 NDA Allergan, Inc. 0023-5861 0023-5861-11 30 PACKET in 1 CARTON (0023-5861-11) / 1 g in 1 PACKET (0023-5861-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TRANSDERMALStrength10% (100MG/PACKET)
Approval Date:Jan 27, 2009TE:RLD:Yes
Patent:See Plans and PricingPatent Expiration:Nov 6, 2029Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF PATIENTS WITH AN OVERACTIVE BLADDER WITH SYMPTOMS OF URINARY FREQUENCY, URGENCY, OR URGE INCONTINENCE WITH A SINGLE UNIT DOSE OF 10% OXYBUTYNIN CHLORIDE GEL
Patent:See Plans and PricingPatent Expiration:Mar 26, 2031Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF OVERACTIVE BLADDER BY APPLICATION OF OXYBUTYNIN CHLORIDE GEL TO SKIN
Patent:See Plans and PricingPatent Expiration:Nov 6, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF OVERACTIVE BLADDER BY APPLICATION OF OXYBUTYNIN CHLORIDE GEL TO SKIN

Expired US Patents for NDA 022204

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan GELNIQUE oxybutynin chloride GEL;TRANSDERMAL 022204-001 Jan 27, 2009 See Plans and Pricing See Plans and Pricing
Allergan GELNIQUE oxybutynin chloride GEL;TRANSDERMAL 022204-001 Jan 27, 2009 See Plans and Pricing See Plans and Pricing
Allergan GELNIQUE oxybutynin chloride GEL;TRANSDERMAL 022204-001 Jan 27, 2009 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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