Drug application

ADAPALENE AND BENZOYL PEROXIDE (ADAPALENE, BENZOYL PEROXIDE)

Drugs@FDA ANDA 209641 · ACTAVIS LABS UT INC

Key facts

Drug name ADAPALENE AND BENZOYL PEROXIDE
Active ingredients ADAPALENE, BENZOYL PEROXIDE
Application type ANDA
Application number 209641
Company ACTAVIS LABS UT INC
Dosage forms GEL, TOPICAL
Strength 0.3%;2.5%
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Jun 22, 2022

At a glance

  • 1–9 Submissions
  • None Label versions
  • 1–9 Products
  • 1–9 Therapeutic equivalents
  • Yes FDA letters on file
  • No 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:

Browse all Drugs@FDA applications