Orange Book product

DIFFERIN 0.3%

Orange Book NDA 021753 · GALDERMA LABORATORIES LP · Prescription

Key facts

Proprietary name DIFFERIN
Active ingredients ADAPALENE
Strength 0.3%
Dosage form GEL
Route TOPICAL
Application NDA021753
Applicant holder GALDERMA LABORATORIES LP
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) Yes
Reference standard (RS) Yes
Approval date Jun 19, 2007

At a glance

  • 1–9 Marketed products with the same ingredient, strength and form
  • 1–9 Products in this application
  • Yes Reference listed drug

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Orange Book products

The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.

Source: U.S. Food and Drug Administration (FDA), Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)

Browse all Orange Book products