Details for New Drug Application (NDA): 022204

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NDA 022204 describes GELNIQUE, which is a drug marketed by Abbvie and Allergan and is included in two NDAs. It is available from one supplier. There are three 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:	Abbvie
Ingredient:	oxybutynin chloride
Patents:	3

Pharmacology for NDA: 022204

Mechanism of Action	Cholinergic Muscarinic Antagonists

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:	DISCN	Dosage:	GEL;TRANSDERMAL			Strength	10% (100MG/PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jan 27, 2009	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Nov 6, 2029	Product Flag?	Y	Substance 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:	⤷ Sign Up	Patent Expiration:	Mar 26, 2031	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF OVERACTIVE BLADDER BY APPLICATION OF OXYBUTYNIN CHLORIDE GEL TO SKIN
Patent:	⤷ Sign Up	Patent Expiration:	Nov 6, 2029	Product 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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	GELNIQUE	oxybutynin chloride	GEL;TRANSDERMAL	022204-001	Jan 27, 2009	⤷ Sign Up	⤷ Sign Up
Abbvie	GELNIQUE	oxybutynin chloride	GEL;TRANSDERMAL	022204-001	Jan 27, 2009	⤷ Sign Up	⤷ Sign Up
Abbvie	GELNIQUE	oxybutynin chloride	GEL;TRANSDERMAL	022204-001	Jan 27, 2009	⤷ Sign Up	⤷ Sign Up
Abbvie	GELNIQUE	oxybutynin chloride	GEL;TRANSDERMAL	022204-001	Jan 27, 2009	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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