Treats Toxoplasmosis. ANDA 207127, held by Pharmazone. Pyrimethamine.
As of Nov 15, 2026, ANDA 207127 (Pyrimethamine), held by Pharmazone, was first approved by FDA on Feb 28, 2020, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Treatment of Toxoplasmosis: Pyrimethamine is indicated for the treatment of toxoplasmosis when used conjointly with a sulfonamide, since synergism exists with this combination.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 28, 2020 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Pyrimethamine25MG · tablet;oral | Pyrimethamine | 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
