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Details for New Drug Application (NDA): 202513

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NDA 202513 describes GELNIQUE 3%, which is a drug marketed by Allergan Sales Llc and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the GELNIQUE 3% profile page.

The generic ingredient in GELNIQUE 3% 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 NDA: 202513

Tradename:
GELNIQUE 3%
Applicant:
Allergan Sales Llc
Ingredient:
oxybutynin
Patents:4
Therapeutic Class:Genitourinary Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 202513

Suppliers and Packaging for NDA: 202513

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GELNIQUE 3%
oxybutynin
GEL, METERED;TRANSDERMAL 202513 NDA Actavis Pharma, Inc. 52544-041 52544-041-54 1 BOTTLE, PUMP in 1 CARTON (52544-041-54) > 92 g in 1 BOTTLE, PUMP

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL, METERED;TRANSDERMALStrength3%
Approval Date:Dec 7, 2011TE:RLD:Yes
Patent:7,198,801Patent Expiration:Jun 25, 2022Product Flag?YSubstance Flag?Delist Request?
Patent:7,029,694Patent 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:7,179,483Patent 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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