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Details for New Drug Application (NDA): 202211

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NDA 202211 describes OXYTROL FOR WOMEN, which is a drug marketed by Allergan Sales Llc and is included in one NDA. It is available from two suppliers. There are six patents protecting this drug. Additional details are available on the OXYTROL FOR WOMEN profile page.

The generic ingredient in OXYTROL FOR WOMEN 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: 202211

Tradename:
OXYTROL FOR WOMEN
Applicant:
Allergan Sales Llc
Ingredient:
oxybutynin
Patents:6
Therapeutic Class:Genitourinary Agents
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 202211

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXYTROL FOR WOMEN
oxybutynin
FILM, EXTENDED RELEASE;TRANSDERMAL 202211 NDA MSD Consumer Care, Inc. 11523-4311 11523-4311-1 1 PATCH in 1 POUCH (11523-4311-1) > 4 d in 1 PATCH
OXYTROL FOR WOMEN
oxybutynin
FILM, EXTENDED RELEASE;TRANSDERMAL 202211 NDA MSD Consumer Care, Inc. 11523-4322 11523-4322-2 8 PATCH in 1 CARTON (11523-4322-2) > 4 d in 1 PATCH

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength3.9MG/24HR
Approval Date:Jan 25, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:Jan 25, 2016
Regulatory Exclusivity Use:NEW PRODUCT
Patent:6,743,441Patent Expiration:Apr 26, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF PATIENTS WITH AN OVERACTIVE BLADDER
Patent:7,081,249Patent Expiration:Apr 26, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF PATIENTS WITH AN OVERACTIVE BLADDER

Expired Orange Book Patents for NDA: 202211

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan Sales Llc
OXYTROL FOR WOMEN
oxybutynin
FILM, EXTENDED RELEASE;TRANSDERMAL202211-001Jan 25, 20135,601,839► subscribe
Allergan Sales Llc
OXYTROL FOR WOMEN
oxybutynin
FILM, EXTENDED RELEASE;TRANSDERMAL202211-001Jan 25, 20135,834,010► subscribe
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