NDA 21625, held by Hospira. Ascorbic Acid; Biotin; Cyanocobalamin; Dexpanthenol; Ergocalciferol; Folic Acid; Niacinamide; Pyridoxine Hydrochloride; Riboflavin 5'-Phosphate Sodium; Thiamine Hydrochloride; Vitamin A; Vitamin E; Vitamin K.
As of Nov 14, 2026, NDA 21625 (M.V.I. Adult), held by Hospira, was first approved by FDA on Jan 30, 2004, with 8 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 30, 2004 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| M.V.I. Adult200MG/VIAL;0.06MG/VIAL;0.005MG/VIAL;15MG/VIAL;0.005MG/VIAL;0.6MG/VIAL;40MG/VIAL;6MG/VIAL;3.6MG/VIAL;6MG/VIAL;1MG/VIAL;10MG/VIAL;0.15MG/VIAL · injectable;intravenous | Ascorbic Acid; Biotin; Cyanocobalamin; Dexpanthenol; Ergocalciferol; Folic Acid; Niacinamide; Pyridoxine Hydrochloride; Riboflavin 5'-Phosphate Sodium; Thiamine Hydrochloride; Vitamin A; Vitamin E; Vitamin K | DiscontinuedReference drug |
| Dec 16, 2020 | Supplement 24Labeling · Standard review | Approved | |
| Nov 9, 2017 | Supplement 23Labeling · Standard review | Approved | |
| Jun 24, 2015 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Jun 11, 2015 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Jan 21, 2015 | Supplement 18Labeling · Standard review | Approved | |
| Jul 1, 2014 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Mar 19, 2013 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Nov 24, 2009 | Supplement 9Manufacturing | Approved | None posted |
| Jan 30, 2004 | Original applicationNew dosage form · 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
