Treats megaloblastic anemias due to folic acid deficiency. NDA 216395, held by Solubiomix. Folic Acid.
As of Nov 14, 2026, NDA 216395 (Quiofic), held by Solubiomix, was first approved by FDA on Jan 26, 2026, with 0 approved supplements and 0 published complete response letters.
FOLIC ACID oral solution is indicated for the treatment of megaloblastic anemias due to folic acid deficiency in adult and pediatric patients.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 26, 2026 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Quiofic0.2MG/ML · solution;oral | Folic Acid | RxReference drug |
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
