Drug application

CANAGLIFLOZIN (CANAGLIFLOZIN)

Drugs@FDA ANDA 210503 · LAURUS LABS LTD

Key facts

Drug name CANAGLIFLOZIN
Active ingredients CANAGLIFLOZIN
Application type ANDA
Application number 210503
Company LAURUS LABS LTD
Dosage forms TABLET, ORAL
Strength 300MG
Marketing status None (Tentative Approval)
Reference listed drug No
Latest submission status date Sep 29, 2025

At a glance

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

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