Drug application

CETIRIZINE HYDROCHLORIDE ALLERGY (CETIRIZINE HYDROCHLORIDE)

Drugs@FDA ANDA 078862 · ORBION PHARMS

Key facts

Drug name CETIRIZINE HYDROCHLORIDE ALLERGY
Active ingredients CETIRIZINE HYDROCHLORIDE
Application type ANDA
Application number 078862
Company ORBION PHARMS
Dosage forms TABLET, ORAL
Strength 5MG
Marketing status Over-the-counter
Reference listed drug No
Latest submission status date Feb 19, 2009

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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