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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 021351


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NDA 021351 describes OXYTROL, which is a drug marketed by Allergan and Abbvie and is included in two NDAs. It is available from one supplier. 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. One supplier is listed for this compound. Additional details are available on the oxybutynin profile page.
Summary for 021351
Tradename:OXYTROL
Applicant:Allergan
Ingredient:oxybutynin
Patents:0
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

Profile for product number 002

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

Expired US Patents for NDA 021351

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

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