Drug application

LINAGLIPTIN (LINAGLIPTIN)

Drugs@FDA ANDA 213602 · MACLEODS PHARMS LTD

Key facts

Drug name LINAGLIPTIN
Active ingredients LINAGLIPTIN
Application type ANDA
Application number 213602
Company MACLEODS PHARMS LTD
Dosage forms TABLET, ORAL
Strength 5MG
Marketing status None (Tentative Approval)
Reference listed drug No
Latest submission status date Aug 7, 2026

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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