Drug application

ZALEPLON (ZALEPLON)

Drugs@FDA ANDA 077239 · TEVA PHARMS

Key facts

Drug name ZALEPLON
Active ingredients ZALEPLON
Application type ANDA
Application number 077239
Company TEVA PHARMS
Dosage forms CAPSULE, ORAL
Strength 5MG
Marketing status Discontinued
Reference listed drug No
Latest submission status date Jun 6, 2008

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • 1–9 Label versions
  • 1–9 Products
  • None Therapeutic equivalents
  • Yes FDA letters on file
  • No 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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