ANDA 202522, held by Xgen Pharms. Folic Acid.
As of Nov 15, 2026, ANDA 202522 (Folic Acid), held by Xgen Pharms, was first approved by FDA on Nov 6, 2019, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Folic Acid Injection, USP alone is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid as may be seen in tropical or nontropical sprue, in anemias of nutritional origin, pregnancy, infancy or childhood.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 6, 2019 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Folic Acid5MG/ML · injectable;injection | 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
