Drug application

AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN, CLAVULANATE POTASSIUM)

Drugs@FDA ANDA 065089 · CHARTWELL RX

Key facts

Drug name AMOXICILLIN AND CLAVULANATE POTASSIUM
Active ingredients AMOXICILLIN, CLAVULANATE POTASSIUM
Application type ANDA
Application number 065089
Company CHARTWELL RX
Dosage forms FOR SUSPENSION, ORAL
Strength 200MG/5ML;EQ 28.5MG BASE/5ML
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date May 25, 2004

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • None Label versions
  • 1–9 Products
  • 1–9 Therapeutic equivalents
  • No 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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