NDA 21643, 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 15, 2026, NDA 21643 (M.V.I. Adult (Pharmacy Bulk Package)), held by Hospira, was first approved by FDA on Feb 18, 2004, with 4 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 18, 2004 | Original applicationNew indication · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| M.V.I. Adult (Pharmacy Bulk Package)200MG/5ML;0.06MG/5ML;0.005MG/5ML;15MG/5ML;0.005MG/5ML;0.6MG/5ML;40MG/5ML;6MG/5ML;3.6MG/5ML;6MG/5ML;1MG/5ML;10MG/5ML;0.15MG/5ML · 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 |
| Nov 9, 2017 | Supplement 19Labeling · Standard review | Approved | |
| Jan 21, 2015 | Supplement 15Labeling · Standard review | Approved | |
| Mar 19, 2013 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Nov 24, 2009 | Supplement 8Manufacturing | Approved | None posted |
| Feb 18, 2004 | Original applicationNew indication · 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
