Drug application

CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY (CETIRIZINE HYDROCHLORIDE)

Drugs@FDA ANDA 078692 · SANDOZ

Key facts

Drug name CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY
Active ingredients CETIRIZINE HYDROCHLORIDE
Application type ANDA
Application number 078692
Company SANDOZ
Dosage forms TABLET, CHEWABLE, ORAL
Strength 5MG
Marketing status Over-the-counter
Reference listed drug No
Latest submission status date Feb 14, 2008

At a glance

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