Drug application

ODOMZO (SONIDEGIB PHOSPHATE)

Drugs@FDA NDA 205266 · SUN PHARM

Key facts

Drug name ODOMZO
Active ingredients SONIDEGIB PHOSPHATE
Application type NDA
Application number 205266
Company SUN PHARM
Dosage forms CAPSULE, ORAL
Strength EQ 200MG BASE
Marketing status Prescription
Reference listed drug Yes
Latest submission class Type 1 - New Molecular Entity
Latest submission status date Jul 24, 2015

At a glance

  • 1–9 Submissions
  • 1–9 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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