Drug application

DEXTENZA (DEXAMETHASONE)

Drugs@FDA NDA 208742 · OCULAR THERAPEUTIX

Key facts

Drug name DEXTENZA
Active ingredients DEXAMETHASONE
Application type NDA
Application number 208742
Company OCULAR THERAPEUTIX
Dosage forms INSERT, OPHTHALMIC
Strength 0.4MG
Marketing status Prescription
Reference listed drug Yes
Latest submission class Type 3 - New Dosage Form
Latest submission status date Nov 30, 2018

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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