Manages signs and symptoms of primary or secondary gout (acute attacks, tophi, joint…. ANDA 203154, held by Accord Hlthcare. Allopurinol.
As of Nov 15, 2026, ANDA 203154 (Allopurinol), held by Accord Hlthcare, was first approved by FDA on May 6, 2013, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE THIS IS NOT AN INNOCUOUS DRUG. IT IS NOT RECOMMENDED FOR THE TREATMENT OF ASYMPTOMATIC HYPERURICEMIA. Allopurinol tablets USP reduces serum and urinary uric acid concentrations. Its use should be individualized for each patient and requires an understanding of its mode of action and pharmacokinetics (see CLINICAL PHARMACOLOGY, CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS ). Allopurinol tablet USP is indicated in: the management of patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy).
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 6, 2013 | Original application | Approved | None posted |
| Allopurinol100MG · tablet;oral | Allopurinol | Rx |
| Allopurinol300MG · tablet;oral | Allopurinol | Rx |
| Feb 11, 2025 | Supplement 9Labeling · Standard review | Approved | None posted |
| May 6, 2013 | Original application | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
