Orange Book product

ALLOPURINOL 300MG

Orange Book ANDA 075798 · PH HEALTH LTD · Prescription

Key facts

Proprietary name ALLOPURINOL
Active ingredients ALLOPURINOL
Strength 300MG
Dosage form TABLET
Route ORAL
Application ANDA075798
Applicant holder PH HEALTH LTD
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Jun 27, 2003

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)

Browse all Orange Book products