Drug application

DAPAGLIFLOZIN AND METFORMIN (DAPAGLIFLOZIN || METFORMIN)

Drugs@FDA ANDA 218091 · SINOTHERAPEUTICS INC

Key facts

Drug name DAPAGLIFLOZIN AND METFORMIN
Active ingredients DAPAGLIFLOZIN || METFORMIN
Application type ANDA
Application number 218091
Company SINOTHERAPEUTICS INC
Dosage forms TABLET
Strength 5MG
Marketing status None (Tentative Approval)
Reference listed drug No
Latest submission status date May 8, 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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