Drug application

AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN, CLAVULANATE POTASSIUM)

Drugs@FDA ANDA 065161 · SUN PHARM INDS LTD

Key facts

Drug name AMOXICILLIN AND CLAVULANATE POTASSIUM
Active ingredients AMOXICILLIN, CLAVULANATE POTASSIUM
Application type ANDA
Application number 065161
Company SUN PHARM INDS LTD
Dosage forms TABLET, CHEWABLE, ORAL
Strength 200MG;EQ 28.5MG BASE
Marketing status Discontinued
Reference listed drug No
Latest submission status date Dec 3, 2003

At a glance

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