Drug application

DIFFERIN (ADAPALENE)

Drugs@FDA NDA 020338 · GALDERMA LABS LP

Key facts

Drug name DIFFERIN
Active ingredients ADAPALENE
Application type NDA
Application number 020338
Company GALDERMA LABS LP
Dosage forms SOLUTION, TOPICAL
Strength 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing status Discontinued
Reference listed drug Yes
Latest submission class Type 1 - New Molecular Entity
Latest submission status date May 31, 1996

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • None Label versions
  • 1–9 Products
  • None Therapeutic equivalents
  • No 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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