M.V.I.-12 Adult

NDA 8809, held by Hospira. Ascorbic Acid; Biotin; Cyanocobalamin; Dexpanthenol; Ergocalciferol; Folic Acid; Niacinamide; Pyridoxine Hydrochloride; Riboflavin 5'-Phosphate Sodium; Thiamine Hydrochloride; Vitamin A; Vitamin E, Ascorbic Acid; Biotin; Cyanocobalamin; Dexpanthenol; Ergocalciferol; Folic Acid; Niacinamide; Pyridoxine Hydrochloride; Riboflavin; Thiamine Hydrochloride; Vitamin A; Vitamin E.

As of Nov 14, 2026, NDA 8809 (M.V.I.-12 Adult), held by Hospira, was first approved by FDA on Feb 20, 1953, with 37 approved supplements and 0 published complete response letters.

First approved: Feb 20, 1953
Review: Standard
Supplements approved: 37
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 38 submissions below


Sep 9, 2004	Supplement 54Efficacy (new indication or use) · Priority review	Approved	Letter Label
Feb 20, 1953	Original applicationNew combination · Standard review	Approved	None posted

Products

3 strengths and forms


M.V.I.-12 Adult10MG/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
M.V.I.-12 Adult20MG/ML;0.006MG/ML;0.5MCG/ML;1.5MG/ML;20 IU/ML;0.6MG/ML;4MG/ML;0.4MG/ML;0.36MG/ML;0.6MG/ML;330 UNITS/ML;1 IU/ML · injectable;injection	Ascorbic Acid; Biotin; Cyanocobalamin; Dexpanthenol; Ergocalciferol; Folic Acid; Niacinamide; Pyridoxine Hydrochloride; Riboflavin; Thiamine Hydrochloride; Vitamin A; Vitamin E	Discontinued
M.V.I.-12 Adult20MG/ML;0.006MG/ML;0.05MCG/ML;1.5MG/ML;0.0005MG/ML;0.06MG/ML;4MG/ML;0.6MG/ML;0.36MG/ML;0.6MG/ML;0.1MG/ML;1MG/ML · injectable;injection	Ascorbic Acid; Biotin; Cyanocobalamin; Dexpanthenol; Ergocalciferol; Folic Acid; Niacinamide; Pyridoxine Hydrochloride; Riboflavin 5'-Phosphate Sodium; Thiamine Hydrochloride; Vitamin A; Vitamin E	DiscontinuedReference drug

All 38 submissions, including labeling and manufacturing supplements


Nov 9, 2017	Supplement 73Labeling · Standard review	Approved	Letter Label
Sep 18, 2015	Supplement 72Manufacturing · Standard review	Approved	None posted
Feb 3, 2015	Supplement 67Manufacturing · Standard review	Approved	None posted
Mar 26, 2013	Supplement 66Labeling	Approved	Label Letter
Mar 19, 2013	Supplement 69Manufacturing · Standard review	Approved	None posted
Jun 14, 2012	Supplement 65Labeling	Approved	Label Letter
Nov 24, 2009	Supplement 60Manufacturing	Approved	None posted
Sep 9, 2004	Supplement 54Efficacy (new indication or use) · Priority review	Approved	Letter Label
Apr 22, 2004	Supplement 52Manufacturing · Standard review	Approved	Label Letter
Nov 14, 2002	Supplement 48Manufacturing · Standard review	Approved	None posted
Jun 4, 2002	Supplement 47Manufacturing · Standard review	Approved	None posted
Jun 4, 2002	Supplement 46Labeling · Standard review	Approved	Letter
Apr 17, 2001	Supplement 45Manufacturing · Standard review	Approved	None posted
Apr 17, 2001	Supplement 44Manufacturing · Standard review	Approved	None posted
Apr 10, 2001	Supplement 43Manufacturing · Standard review	Approved	None posted
Aug 2, 1999	Supplement 42Manufacturing · Standard review	Approved	None posted
May 25, 1999	Supplement 41Manufacturing · Standard review	Approved	None posted
Nov 18, 1998	Supplement 40Manufacturing · Standard review	Approved	None posted
May 12, 1998	Supplement 39Manufacturing · Standard review	Approved	None posted
Mar 30, 1998	Supplement 37Manufacturing · Standard review	Approved	None posted
Dec 31, 1997	Supplement 38Manufacturing · Standard review	Approved	None posted
Sep 22, 1997	Supplement 36Manufacturing · Standard review	Approved	None posted
Feb 13, 1997	Supplement 35Manufacturing · Standard review	Approved	None posted
Jan 19, 1996	Supplement 33Manufacturing · Standard review	Approved	None posted
Oct 27, 1995	Supplement 31Manufacturing · Standard review	Approved	None posted
May 26, 1995	Supplement 30Manufacturing · Standard review	Approved	None posted
Feb 24, 1993	Supplement 29Manufacturing · Standard review	Approved	None posted
Feb 3, 1993	Supplement 28Manufacturing · Standard review	Approved	None posted
Feb 2, 1993	Supplement 27Manufacturing · Standard review	Approved	None posted
Apr 19, 1991	Supplement 25Labeling	Approved	None posted
Dec 7, 1990	Supplement 24Manufacturing · Standard review	Approved	None posted
Jun 22, 1989	Supplement 23Labeling	Approved	None posted
Aug 8, 1985	Supplement 21Labeling	Approved	None posted
Apr 25, 1985	Supplement 19Manufacturing · Standard review	Approved	None posted
Apr 24, 1985	Supplement 20Manufacturing · Standard review	Approved	None posted
Sep 20, 1984	Supplement 18Labeling	Approved	None posted
Jun 23, 1980	Supplement 5Labeling	Approved	None posted
Feb 20, 1953	Original applicationNew combination · Standard review	Approved	None posted

Identifiers

Application: NDA 8809
Drugs@FDA: Overview at FDA
Company: Hospira

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