Drug application

TOBI PODHALER (TOBRAMYCIN)

Drugs@FDA NDA 201688 · VIATRIS

Key facts

Drug name TOBI PODHALER
Active ingredients TOBRAMYCIN
Application type NDA
Application number 201688
Company VIATRIS
Dosage forms POWDER, INHALATION
Strength 28MG
Marketing status Prescription
Reference listed drug Yes
Latest submission class Type 3 - New Dosage Form
Latest submission status date Mar 22, 2013

At a glance

  • 1–9 Submissions
  • 10–99 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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