Drug application

SITAGLIPTIN AND METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE, SITAGLIPTIN)

Drugs@FDA ANDA 216288 · MSN LABORATORIES PRIVATE LTD

Key facts

Drug name SITAGLIPTIN AND METFORMIN HYDROCHLORIDE
Active ingredients METFORMIN HYDROCHLORIDE, SITAGLIPTIN
Application type ANDA
Application number 216288
Company MSN LABORATORIES PRIVATE LTD
Dosage forms TABLET, COATED
Strength 50MG
Marketing status None (Tentative Approval)
Reference listed drug No
Latest submission status date Jul 14, 2025

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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