Drug application

EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE (EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE)

Drugs@FDA ANDA 217781 · AJANTA PHARMA LTD

Key facts

Drug name EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Active ingredients EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE
Application type ANDA
Application number 217781
Company AJANTA PHARMA LTD
Dosage forms TABLET, ORAL
Strength 12.5MG;1000MG
Marketing status None (Tentative Approval)
Reference listed drug No
Latest submission status date Jan 23, 2025

At a glance

  • 1–9 Submissions
  • None Label versions
  • None 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

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