NDA 6012, held by Lederle. Ferrous Sulfate; Folic Acid.
As of Nov 14, 2026, NDA 6012 (Folvron), held by Lederle, was first approved by FDA on Aug 13, 1946, with 2 approved supplements and 0 published complete response letters.
| Dec 14, 1981 | Supplement 6Efficacy (new indication or use) | Approved | None posted |
| Oct 14, 1980 | Supplement 3Efficacy (new indication or use) | Approved | None posted |
| Aug 13, 1946 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Folvron182MG;0.33MG ยท capsule;oral | Ferrous Sulfate; Folic Acid | Discontinued |
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
