Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 008809
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
M.V.I.-12 ADULT ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E 10MG/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 Discontinued None No No
M.V.I.-12 ADULT ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E 20MG/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 Discontinued None No No
M.V.I.-12 ADULT ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E 20MG/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 Discontinued None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/20/1953 ORIG-1 Approval Type 4 - New Combination STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/09/2017 SUPPL-73 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/008809s073lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/008809Orig1s073ltr.pdf
09/18/2015 SUPPL-72 Manufacturing (CMC)

Label is not available on this site.

03/19/2013 SUPPL-69 Manufacturing (CMC)

Label is not available on this site.

02/03/2015 SUPPL-67 Manufacturing (CMC)

Label is not available on this site.

03/26/2013 SUPPL-66 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/008809s066lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/008809Orig1s066ltr.pdf
06/14/2012 SUPPL-65 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/008809s065lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/008809s065ltr.pdf
11/24/2009 SUPPL-60 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

09/09/2004 SUPPL-54 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/08809s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/08809s054ltr.pdf
04/22/2004 SUPPL-52 Manufacturing (CMC)-Formulation Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/08809scf052_mvi-12_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/08809scf052ltr.pdf
11/14/2002 SUPPL-48 Manufacturing (CMC)-Control

Label is not available on this site.

06/04/2002 SUPPL-47 Manufacturing (CMC)-Control

Label is not available on this site.

06/04/2002 SUPPL-46 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/8809s046ltr.pdf
04/17/2001 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

04/17/2001 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

04/10/2001 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

08/02/1999 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.

05/25/1999 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

11/18/1998 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

05/12/1998 SUPPL-39 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/31/1997 SUPPL-38 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/30/1998 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

09/22/1997 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

02/13/1997 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

01/19/1996 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

10/27/1995 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

05/26/1995 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

02/24/1993 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

02/03/1993 SUPPL-28 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/02/1993 SUPPL-27 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/19/1991 SUPPL-25 Labeling

Label is not available on this site.

12/07/1990 SUPPL-24 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/22/1989 SUPPL-23 Labeling

Label is not available on this site.

08/08/1985 SUPPL-21 Labeling

Label is not available on this site.

04/24/1985 SUPPL-20 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/25/1985 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/20/1984 SUPPL-18 Labeling

Label is not available on this site.

06/23/1980 SUPPL-5 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/09/2017 SUPPL-73 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/008809s073lbl.pdf
11/09/2017 SUPPL-73 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/008809s073lbl.pdf
03/26/2013 SUPPL-66 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/008809s066lbl.pdf
06/14/2012 SUPPL-65 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/008809s065lbl.pdf
09/09/2004 SUPPL-54 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/08809s054lbl.pdf
04/22/2004 SUPPL-52 Manufacturing (CMC)-Formulation Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/08809scf052_mvi-12_lbl.pdf

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