Drug application

GELNIQUE 3% (OXYBUTYNIN)

Drugs@FDA NDA 202513 · ALLERGAN

Key facts

Drug name GELNIQUE 3%
Active ingredients OXYBUTYNIN
Application type NDA
Application number 202513
Company ALLERGAN
Dosage forms GEL, METERED, TRANSDERMAL
Strength 3%
Marketing status Discontinued
Reference listed drug Yes
Latest submission class Type 5 - New Formulation or New Manufacturer
Latest submission status date Dec 7, 2011

At a glance

  • 1–9 Submissions
  • 1–9 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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