Drug application

CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE (CANAGLIFLOZIN, METFORMIN HYDROCHLORIDE)

Drugs@FDA ANDA 213900 · AUROBINDO PHARMA LIMITED

Key facts

Drug name CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
Active ingredients CANAGLIFLOZIN, METFORMIN HYDROCHLORIDE
Application type ANDA
Application number 213900
Company AUROBINDO PHARMA LIMITED
Dosage forms TABLET, EXTENDED RELEASE
Strength 50MG
Marketing status None (Tentative Approval)
Reference listed drug No
Latest submission status date Aug 11, 2026

At a glance

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

Browse all Drugs@FDA applications