Drug application

NITAZOXANIDE (NITAZOXANIDE)

Drugs@FDA ANDA 213820 · RISING

Key facts

Drug name NITAZOXANIDE
Active ingredients NITAZOXANIDE
Application type ANDA
Application number 213820
Company RISING
Dosage forms TABLET, ORAL
Strength 500MG
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Nov 27, 2020

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • None Label versions
  • 1–9 Products
  • 1–9 Therapeutic equivalents
  • Yes FDA letters on file
  • No 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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