Drug application

ORALTAG (IOHEXOL)

Drugs@FDA NDA 205383 · INTERPHARMA PRAHA AS

Key facts

Drug name ORALTAG
Active ingredients IOHEXOL
Application type NDA
Application number 205383
Company INTERPHARMA PRAHA AS
Dosage forms FOR SOLUTION, ORAL
Strength 9.7GM/BOT
Marketing status Discontinued
Reference listed drug No
Latest submission class Type 3 - New Dosage Form
Latest submission status date Mar 26, 2015

At a glance

  • 1–9 Submissions
  • 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:

Browse all Drugs@FDA applications