Drug application

ADAPALENE AND BENZOYL PEROXIDE (ADAPALENE, BENZOYL PEROXIDE)

Drugs@FDA ANDA 217384 · AUROBINDO PHARMA LTD

Key facts

Drug name ADAPALENE AND BENZOYL PEROXIDE
Active ingredients ADAPALENE, BENZOYL PEROXIDE
Application type ANDA
Application number 217384
Company AUROBINDO PHARMA LTD
Dosage forms GEL, TOPICAL
Strength 0.3%;2.5%
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Jul 22, 2026

At a glance

  • 1–9 Submissions
  • None Label versions
  • 1–9 Products
  • 1–9 Therapeutic equivalents

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

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