Drug application

SITAGLIPTIN AND METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE)

Drugs@FDA ANDA 204144 · PH HEALTH

Key facts

Drug name SITAGLIPTIN AND METFORMIN HYDROCHLORIDE
Active ingredients METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE
Application type ANDA
Application number 204144
Company PH HEALTH
Dosage forms TABLET, EXTENDED RELEASE, ORAL
Strength 500MG;EQ 50MG BASE
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Jun 4, 2025

At a glance

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