Drug application

SITAGLIPTIN AND METFORMIN HYDROCHLORIDE (SITAGLIPTIN, METFORMIN HYDROCHLORIDE)

Drugs@FDA ANDA 218405 · MANKIND PHARMA LTD

Key facts

Drug name SITAGLIPTIN AND METFORMIN HYDROCHLORIDE
Active ingredients SITAGLIPTIN, METFORMIN HYDROCHLORIDE
Application type ANDA
Application number 218405
Company MANKIND PHARMA LTD
Dosage forms TABLET
Strength 50MG
Marketing status None (Tentative Approval)
Reference listed drug No
Latest submission status date May 21, 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

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