Treats scurvy. NDA 209112, held by Mcguff. Ascorbic Acid.
As of Nov 13, 2026, NDA 209112 (Ascor), held by Mcguff, was first approved by FDA on Oct 2, 2017, with 3 approved supplements and 0 published complete response letters.
1. INDICATIONS AND USAGE ASCOR is vitamin C indicated for the short term (up to 1 week) treatment of scurvy in adult and pediatric patients age 5 months and older for whom oral administration is not possible, insufficient or contraindicated. Limitations of Use ASCOR is not indicated for treatment of vitamin C deficiency that is not associated with signs and symptoms of scurvy. ASCOR is vitamin C
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 2, 2017 | Original applicationTYPE 7 · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ascor25,000MG/50ML (500MG/ML) · solution;intravenous | Ascorbic Acid | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 17, 2024 | Supplement 9Manufacturing · Standard review | Approved | |
| Apr 23, 2023 | Supplement 8Manufacturing | Approved | |
| Jul 8, 2022 | Supplement 7Labeling · Standard review | Approved | |
| Oct 2, 2017 | Original applicationTYPE 7 · Standard review | Approved |
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
