ANDA 211064, held by Rising. Folic Acid.
As of Nov 15, 2026, ANDA 211064 (Folic Acid), held by Rising, was first approved by FDA on Mar 8, 2019, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Folic acid, USP is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid, USP (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 8, 2019 | 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
