Drug application

AUGMENTIN '125' (AMOXICILLIN, CLAVULANATE POTASSIUM)

Drugs@FDA NDA 050575 · US ANTIBIOTICS

Key facts

Drug name AUGMENTIN '125'
Active ingredients AMOXICILLIN, CLAVULANATE POTASSIUM
Application type NDA
Application number 050575
Company US ANTIBIOTICS
Dosage forms FOR SUSPENSION, ORAL
Strength 125MG/5ML;EQ 31.25MG BASE/5ML
Marketing status Prescription
TE codes AB
Reference listed drug Yes
Latest submission class Type 3 - New Dosage Form
Latest submission status date Aug 6, 1984

At a glance

  • 1–9 Submissions
  • 10–99 Supplements
  • 1–9 Label versions
  • 1–9 Products
  • 1–9 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 · Source date:

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