Treats chronic gouty arthritis. ANDA 40618, held by Ingenus Pharms LLC. Colchicine; Probenecid.
As of Nov 15, 2026, ANDA 40618 (Probenecid And Colchicine), held by Ingenus Pharms LLC, was first approved by FDA on May 13, 2008, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE For the treatment of chronic gouty arthritis when complicated by frequent, recurrent acute attacks of gout.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 13, 2008 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Probenecid And Colchicine0.5MG;500MG · tablet;oral | Colchicine; Probenecid | Rx |
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
