Drug application

METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)

Drugs@FDA ANDA 209313 · GRANULES

Key facts

Drug name METFORMIN HYDROCHLORIDE
Active ingredients METFORMIN HYDROCHLORIDE
Application type ANDA
Application number 209313
Company GRANULES
Dosage forms TABLET, EXTENDED RELEASE, ORAL
Strength 500MG
Marketing status Prescription
TE codes AB1
Reference listed drug No
Latest submission status date Mar 16, 2018

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • None Label versions
  • 1–9 Products
  • 10–99 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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