Drug application

ALPRAZOLAM (ALPRAZOLAM)

Drugs@FDA ANDA 078088 · PH HEALTH

Key facts

Drug name ALPRAZOLAM
Active ingredients ALPRAZOLAM
Application type ANDA
Application number 078088
Company PH HEALTH
Dosage forms TABLET, ORALLY DISINTEGRATING, ORAL
Strength 0.25MG
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Jan 9, 2009

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • None Label versions
  • 1–9 Products
  • 10–99 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:

Browse all Drugs@FDA applications