Drug application

LINAGLIPTIN AND METFORMIN HYDROCHLORIDE (LINAGLIPTIN AND METFORMIN HYDROCHLORIDE)

Drugs@FDA ANDA 208454 · SUN PHARM INDS LTD

Key facts

Drug name LINAGLIPTIN AND METFORMIN HYDROCHLORIDE
Active ingredients LINAGLIPTIN AND METFORMIN HYDROCHLORIDE
Application type ANDA
Application number 208454
Company SUN PHARM INDS LTD
Dosage forms TABLET, ORAL
Strength 2.5MG/500MG
Marketing status None (Tentative Approval)
Reference listed drug No
Latest submission status date May 28, 2020

At a glance

  • 1–9 Submissions
  • None Label versions
  • 1–9 Products
  • None Therapeutic equivalents
  • Yes FDA letters on file
  • No FDA reviews on file

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 · Source date:

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