ANDA 203924, held by Alvogen. Primaquine Phosphate.
As of Nov 15, 2026, ANDA 203924 (Primaquine Phosphate), held by Alvogen, was first approved by FDA on Feb 3, 2014, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 3, 2014 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Primaquine PhosphateEQ 15MG BASE · tablet;oral | Primaquine Phosphate | Discontinued |
| Sep 14, 2026 | Supplement 2Labeling · Standard review | Approved | None posted |
| Aug 15, 2025 | Supplement 1Labeling · Standard review | Approved | None posted |
| Feb 3, 2014 | Original application | 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
