Drug application

OXYTROL (OXYBUTYNIN)

Drugs@FDA NDA 021351 · ALLERGAN

Key facts

Drug name OXYTROL
Active ingredients OXYBUTYNIN
Application type NDA
Application number 021351
Company ALLERGAN
Dosage forms FILM, EXTENDED RELEASE, TRANSDERMAL
Strength 3.9MG/24HR
Marketing status Prescription
Reference listed drug Yes
Latest submission class Type 3 - New Dosage Form
Latest submission status date Feb 26, 2003

At a glance

  • 1–9 Submissions
  • 10–99 Supplements
  • 1–9 Label versions
  • 1–9 Products
  • None Therapeutic equivalents
  • Yes FDA letters on file
  • Yes FDA reviews on file

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Drugs@FDA applications

Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.

Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date:

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