ANDA 40796, held by Leading. Folic Acid.
As of Nov 15, 2026, ANDA 40796 (Folic Acid), held by Leading, was first approved by FDA on Jan 12, 2009, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Folic acid is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 12, 2009 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Folic Acid1MG · tablet;oral | Folic Acid | 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
