Orange Book product

ALLOPURINOL 300MG

Orange Book ANDA 018659 · MYLAN PHARMACEUTICALS INC · Prescription

Key facts

Proprietary name ALLOPURINOL
Active ingredients ALLOPURINOL
Strength 300MG
Dosage form TABLET
Route ORAL
Application ANDA018659
Applicant holder MYLAN PHARMACEUTICALS INC
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Oct 24, 1986

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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