Drug application

ONDANSETRON HYDROCHLORIDE (ONDANSETRON HYDROCHLORIDE)

Drugs@FDA ANDA 078539 · AUROBINDO PHARMA

Key facts

Drug name ONDANSETRON HYDROCHLORIDE
Active ingredients ONDANSETRON HYDROCHLORIDE
Application type ANDA
Application number 078539
Company AUROBINDO PHARMA
Dosage forms TABLET, ORAL
Strength EQ 4MG BASE
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Jul 31, 2007

At a glance

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

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

Browse all Drugs@FDA applications