Orange Book product

ALLOPURINOL 100MG

Orange Book ANDA 211820 · UNICHEM LABORATORIES LTD · Prescription

Key facts

Proprietary name ALLOPURINOL
Active ingredients ALLOPURINOL
Strength 100MG
Dosage form TABLET
Route ORAL
Application ANDA211820
Applicant holder UNICHEM LABORATORIES LTD
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Mar 12, 2019

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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