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Last Updated: December 7, 2019

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Details for New Drug Application (NDA): 021351

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NDA 021351 describes OXYTROL, which is a drug marketed by Allergan Sales Llc and is included in two NDAs. It is available from two suppliers. There are six patents protecting this drug and one Paragraph IV challenge. Additional details are available on the OXYTROL profile page.

The generic ingredient in OXYTROL 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 021351
Tradename:OXYTROL
Applicant:Allergan Sales Llc
Ingredient:oxybutynin
Patents:6
Formulation / Manufacturing:see details
Pharmacology for NDA: 021351
Suppliers and Packaging for NDA: 021351
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXYTROL oxybutynin FILM, EXTENDED RELEASE;TRANSDERMAL 021351 NDA Allergan, Inc. 0023-6153 0023-6153-08 8 POUCH in 1 BOX (0023-6153-08) > 1 PATCH in 1 POUCH > 4 d in 1 PATCH
OXYTROL oxybutynin FILM, EXTENDED RELEASE;TRANSDERMAL 021351 NDA Actavis Pharma, Inc. 52544-920 52544-920-08 8 POUCH in 1 BOX (52544-920-08) > 1 PATCH in 1 POUCH (52544-920-54) > 4 d in 1 PATCH
Paragraph IV (Patent) Challenges for 021351
Tradename Dosage Ingredient NDA Submissiondate
OXYTROL FILM, EXTENDED RELEASE;TRANSDERMAL oxybutynin 021351 2008-08-19

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength3.9MG/24HR
Approval Date:Feb 26, 2003TE:RLD:Yes
Patent:  Start TrialPatent 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:  Start TrialPatent 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:  Start TrialPatent 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

Expired US Patents for NDA 021351

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan Sales Llc OXYTROL oxybutynin FILM, EXTENDED RELEASE;TRANSDERMAL 021351-002 Feb 26, 2003   Start Trial   Start Trial
Allergan Sales Llc OXYTROL oxybutynin FILM, EXTENDED RELEASE;TRANSDERMAL 021351-002 Feb 26, 2003   Start Trial   Start Trial
Allergan Sales Llc OXYTROL oxybutynin FILM, EXTENDED RELEASE;TRANSDERMAL 021351-002 Feb 26, 2003   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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