Drug application

Oxybutynin Chloride (Oxybutynin Chloride)

Drugs@FDA ANDA 078293 · MYLAN PHARMS INC

Key facts

Drug name Oxybutynin Chloride
Active ingredients Oxybutynin Chloride
Application type ANDA
Application number 078293
Company MYLAN PHARMS INC
Dosage forms TABLET, EXTENDED RELEASE, ORAL
Strength 15 MG.
Marketing status Prescription
TE codes TBD
Reference listed drug Yes
Latest submission status date May 10, 2007

At a glance

  • 1–9 Submissions
  • None Label versions
  • 1–9 Products
  • 1–9 Therapeutic equivalents
  • No 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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