NDA 18440, held by Abraxis Pharm. Ascorbic Acid; Biotin; Cyanocobalamin; Dexpanthenol; Ergocalciferol; Folic Acid; Niacinamide; Pyridoxine Hydrochloride; Riboflavin 5'-Phosphate Sodium; Thiamine Hydrochloride; Vitamin A; Vitamin E.
As of Nov 13, 2026, NDA 18440 (M.V.C. 9+3), held by Abraxis Pharm, was first approved by FDA on Nov 6, 1981, with 8 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 6, 1981 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| M.V.C. 9+310MG/ML;0.006MG/ML;0.5MCG/ML;1.5MG/ML;20 IU/ML;0.04MG/ML;4MG/ML;0.4MG/ML;0.36MG/ML;0.3MG/ML;330 UNITS/ML;1 IU/ML · injectable;injection | Ascorbic Acid; Biotin; Cyanocobalamin; Dexpanthenol; Ergocalciferol; Folic Acid; Niacinamide; Pyridoxine Hydrochloride; Riboflavin 5'-Phosphate Sodium; Thiamine Hydrochloride; Vitamin A; Vitamin E | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 26, 1996 | Supplement 24Labeling | Approved | None posted |
| Apr 26, 1996 | Supplement 15Labeling | Approved | None posted |
| Apr 26, 1996 | Supplement 12Labeling | Approved | None posted |
| Apr 26, 1996 | Supplement 6Labeling | Approved | None posted |
| Jul 1, 1992 | Supplement 30Labeling | Approved | None posted |
| Jun 30, 1992 | Supplement 27Labeling | Approved | None posted |
| Nov 18, 1982 | Supplement 4Labeling | Approved | None posted |
| May 5, 1982 | Supplement 2Labeling | Approved | None posted |
| Nov 6, 1981 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
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
