Manages signs and symptoms of primary or secondary gout (acute attacks, tophi, joint…. ANDA 214443, held by Harman Finochem. Allopurinol.
As of Nov 15, 2026, ANDA 214443 (Allopurinol), held by Harman Finochem, was first approved by FDA on Mar 7, 2022, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 7, 2022 | Original application | Approved | None posted |
| Allopurinol100MG · tablet;oral | Allopurinol | Rx |
| Allopurinol300MG · tablet;oral | Allopurinol | Rx |
| Allopurinol200MG · tablet;oral | Allopurinol | Rx |
| Mar 8, 2024 | Supplement 2Labeling · Standard review | Approved | None posted |
| Mar 7, 2022 | 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
