ANDA 40625, held by Amneal Pharm. Folic Acid.
As of Nov 15, 2026, ANDA 40625 (Folic Acid), held by Amneal Pharm, was first approved by FDA on Jul 21, 2005, 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 |
|---|---|---|---|
| Jul 21, 2005 | 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
