Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018920
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
M.V.I. PEDIATRIC ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PHYTONADIONE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E 80MG/VIAL;0.02MG/VIAL;0.001MG/VIAL;5MG/VIAL;0.01MG/VIAL;0.14MG/VIAL;17MG/VIAL;0.2MG/VIAL;1MG/VIAL;1.4MG/VIAL;EQ 1.2MG BASE/VIAL;0.7MG/VIAL;7MG/VIAL FOR SOLUTION;INTRAVENOUS Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/06/1983 ORIG-1 Approval Type 4 - New Combination PRIORITY; Orphan

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/14/2019 SUPPL-38 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018920s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/018920Orig1s038ltr.pdf
11/09/2017 SUPPL-36 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018920s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018920Orig1s036ltr.pdf
06/27/2013 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

11/30/2001 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

07/09/2002 SUPPL-24 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18920s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18920slr024ltr.pdf
06/05/2001 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

11/02/2000 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

09/21/2000 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

09/21/2000 SUPPL-20 Labeling

Label is not available on this site.

06/05/2001 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

04/12/2000 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

08/13/1999 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

12/16/1998 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

03/25/1998 SUPPL-15 Labeling

Label is not available on this site.

04/09/1996 SUPPL-14 Labeling

Label is not available on this site.

01/19/1996 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

10/18/1995 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

05/26/1995 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

02/24/1993 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/22/1993 SUPPL-8 Labeling

Label is not available on this site.

04/19/1991 SUPPL-7 Labeling

Label is not available on this site.

06/22/1989 SUPPL-6 Labeling

Label is not available on this site.

12/08/1986 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

12/03/1986 SUPPL-4 Labeling

Label is not available on this site.

05/15/1985 SUPPL-3 Labeling

Label is not available on this site.

07/06/1984 SUPPL-2 Labeling

Label is not available on this site.

07/06/1984 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/14/2019 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018920s038lbl.pdf
11/09/2017 SUPPL-36 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018920s036lbl.pdf
07/09/2002 SUPPL-24 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18920s024lbl.pdf

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