Drug application

INTERMEZZO (ZOLPIDEM TARTRATE)

Drugs@FDA NDA 022328 · PURDUE PHARMA

Key facts

Drug name INTERMEZZO
Active ingredients ZOLPIDEM TARTRATE
Application type NDA
Application number 022328
Company PURDUE PHARMA
Dosage forms TABLET, SUBLINGUAL
Strength 1.75MG
Marketing status Discontinued
Reference listed drug Yes
Latest submission class Type 3 - New Dosage Form
Latest submission status date Nov 23, 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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