Treats acute lymphoblastic leukemia (ALL). NDA 205919, held by Nova Labs Ltd. Mercaptopurine.
As of Nov 14, 2026, NDA 205919 (Purixan), held by Nova Labs Ltd, was first approved by FDA on Apr 28, 2014, with 7 approved supplements and 0 published complete response letters.
MERCAPTOPURINE is a nucleoside metabolic inhibitor indicated for the treatment of patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen. 1.1 Acute Lymphoblastic Leukemia
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 28, 2014 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Purixan20MG/ML · suspension;oral | Mercaptopurine | RxReference drug |
| Jul 16, 2026 | Supplement 9Labeling · Standard review | Approved | |
| Oct 23, 2024 | Supplement 7Labeling · Standard review | Approved | |
| Jul 9, 2024 | Supplement 8Labeling · Standard review | Approved | |
| Apr 7, 2020 | Supplement 4Labeling · Standard review | Approved | |
| Feb 20, 2018 | Supplement 3Labeling · Standard review | Approved | |
| May 8, 2017 | Supplement 2Labeling · Standard review | Approved | |
| Dec 23, 2014 | Supplement 1Manufacturing · Standard review | Approved | |
| Apr 28, 2014 | Original applicationNew formulation or manufacturer · Standard review | Approved |
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
