Orange Book product

CETIRIZINE HYDROCHLORIDE HIVES 5MG

Orange Book ANDA 078343 · DR REDDYS LABORATORIES LTD · Over the counter

Key facts

Proprietary name CETIRIZINE HYDROCHLORIDE HIVES
Active ingredients CETIRIZINE HYDROCHLORIDE
Strength 5MG
Dosage form TABLET
Route ORAL
Application ANDA078343
Applicant holder DR REDDYS LABORATORIES LTD
Marketing status Over the counter
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Jan 15, 2008

At a glance

  • 10–99 Marketed products with the same ingredient, strength and form
  • 1–9 Products in this application
  • No Reference listed drug

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Orange Book products

The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.

Source: U.S. Food and Drug Administration (FDA), Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)

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