Drug application

METAXALONE (METAXALONE)

Drugs@FDA ANDA 040445 · SANDOZ

Key facts

Drug name METAXALONE
Active ingredients METAXALONE
Application type ANDA
Application number 040445
Company SANDOZ
Dosage forms TABLET, ORAL
Strength 800MG
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Mar 31, 2010

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • None Label versions
  • 1–9 Products
  • 1–9 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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