Drug application

KAZANO (ALOGLIPTIN BENZOATE, METFORMIN HYDROCHLORIDE)

Drugs@FDA NDA 203414 · TAKEDA PHARMS USA

Key facts

Drug name KAZANO
Active ingredients ALOGLIPTIN BENZOATE, METFORMIN HYDROCHLORIDE
Application type NDA
Application number 203414
Company TAKEDA PHARMS USA
Dosage forms TABLET, ORAL
Strength EQ 12.5MG BASE;500MG
Marketing status Prescription
Reference listed drug Yes
Latest submission class Type 4 - New Combination
Latest submission status date Jan 25, 2013

At a glance

  • 1–9 Submissions
  • 10–99 Supplements
  • 10–99 Label versions
  • 1–9 Products
  • None Therapeutic equivalents
  • Yes FDA letters on file
  • Yes 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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