Manages signs and symptoms of primary or secondary gout (acute attacks, tophi, joint…. ANDA 211820, held by Unichem. Allopurinol.
As of Nov 15, 2026, ANDA 211820 (Allopurinol), held by Unichem, was first approved by FDA on Mar 12, 2019, with 2 approved supplements and 0 published complete response letters.
Allopurinol tablets are indicated for: The management of adults with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy) The management of adult and pediatric patients with leukemia, lymphoma and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels The management of adult patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients, despite lifestyle changes (such as reduction of dietary sodium, non-dairy animal protein, oxylate rich foods, refined sugars and i…
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 12, 2019 | Original application | Approved | None posted |
| Allopurinol100MG · tablet;oral | Allopurinol | Rx |
| Allopurinol300MG · tablet;oral | Allopurinol | Rx |
| Jan 29, 2024 | Supplement 11Labeling · Standard review | Approved | None posted |
| Jan 12, 2023 | Supplement 6Labeling · Standard review | Approved | None posted |
| Mar 12, 2019 | 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
