Manages signs and symptoms of primary or secondary gout (acute attacks, tophi, joint…. ANDA 204467, held by Regcon Holdings. Allopurinol.
As of Nov 15, 2026, ANDA 204467 (Allopurinol), held by Regcon Holdings, was first approved by FDA on Jul 28, 2016, with 4 approved supplements 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 reduce 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 tablets are indicated in: 1. the management of patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy). 2.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 28, 2016 | Original application | Approved | None posted |
| Allopurinol100MG · tablet;oral | Allopurinol | Rx |
| Allopurinol300MG · tablet;oral | Allopurinol | Rx |
| Allopurinol200MG · tablet;oral | Allopurinol | Rx |
| Oct 16, 2025 | Supplement 18Labeling · Standard review | Approved | None posted |
| Feb 5, 2024 | Supplement 5Labeling · Standard review | Approved | None posted |
| Feb 5, 2024 | Supplement 12Labeling · Standard review | Approved | None posted |
| Mar 15, 2023 | Supplement 7Manufacturing | Approved | None posted |
| Jul 28, 2016 | 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
