Drug application

FLUCONAZOLE (FLUCONAZOLE)

Drugs@FDA ANDA 218692 · FDC LTD

Key facts

Drug name FLUCONAZOLE
Active ingredients FLUCONAZOLE
Application type ANDA
Application number 218692
Company FDC LTD
Dosage forms TABLET, ORAL
Strength 50MG
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Jan 8, 2026

At a glance

  • 1–9 Submissions
  • 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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