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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 one supplier. 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 NDA: 021351

Tradename:
OXYTROL
Applicant:
Allergan Sales Llc
Ingredient:
oxybutynin
Patents:6
Therapeutic Class:Genitourinary Agents
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 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

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength3.9MG/24HR
Approval Date:Feb 26, 2003TE:ABRLD:Yes
Patent:6,743,441Patent 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:7,081,249Patent 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:7,081,250Patent 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 Orange Book Patents for NDA: 021351

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan Sales Llc
OXYTROL
oxybutynin
FILM, EXTENDED RELEASE;TRANSDERMAL021351-002Feb 26, 20035,164,190► subscribe
Allergan Sales Llc
OXYTROL
oxybutynin
FILM, EXTENDED RELEASE;TRANSDERMAL021351-002Feb 26, 20035,834,010► subscribe
Allergan Sales Llc
OXYTROL
oxybutynin
FILM, EXTENDED RELEASE;TRANSDERMAL021351-002Feb 26, 20035,601,839► subscribe
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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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