Drug application

EMPAGLIFLOZIN (EMPAGLIFLOZIN)

Drugs@FDA ANDA 212322 · AIZANT

Key facts

Drug name EMPAGLIFLOZIN
Active ingredients EMPAGLIFLOZIN
Application type ANDA
Application number 212322
Company AIZANT
Dosage forms TABLET, ORAL
Strength 2.5MG
Marketing status None (Tentative Approval)
Reference listed drug No
Latest submission status date Dec 29, 2020

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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