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Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022204

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NDA 022204 describes GELNIQUE, which is a drug marketed by Allergan Sales Llc and is included in two NDAs. It is available from three suppliers. There are six 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. Two suppliers are listed for this compound. Additional details are available on the oxybutynin profile page.

Summary for 022204

Tradename:1
Applicant:1
Ingredient:1
Patents:5
Therapeutic Class:Genitourinary Agents
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. 0023-5812 0023-5812-30 1 BOTTLE, PUMP in 1 CARTON (0023-5812-30) > 30 g in 1 BOTTLE, PUMP
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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TRANSDERMALStrength10%(100MG/PACKET)
Approval Date:Jan 27, 2009TE:RLD:Yes
Patent:► SubscribePatent Expiration:Apr 26, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF PATIENTS WITH AN OVERACTIVE BLADDER WITH SYMPTOMS OF URINARY FREQUENCY, URGENCY, OR URGE INCONTINENCE
Patent:► SubscribePatent Expiration:Apr 26, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF PATIENTS WITH AN OVERACTIVE BLADDER WITH SYMPTOMS OF URINARY FREQUENCY, URGENCY, OR URGE INCONTINENCE
Patent:► SubscribePatent Expiration:Apr 26, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF PATIENTS WITH AN OVERACTIVE BLADDER WITH SYMPTOMS OF URINARY FREQUENCY, URGENCY, OR URGE INCONTINENCE


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Serving leading biopharmaceutical companies globally:

Argus Health
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