Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021163
Company: SANDOZ INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INFUVITE ADULT ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE; VITAMIN K 2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;0.03MG/ML 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
05/18/2000 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21163lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21163ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-163_Multi-12.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/17/2016 SUPPL-32 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021163s032,021559s025lbl.pdf
10/26/2015 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

10/02/2015 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

09/04/2014 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

12/03/2013 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

07/13/2013 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

09/04/2013 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

12/05/2008 SUPPL-16 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021163s016ltr.pdf
08/22/2006 SUPPL-14 Labeling-Container/Carton Labels

Label is not available on this site.

09/17/2004 SUPPL-11 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21163s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21163s011ltr.pdf
02/12/2003 SUPPL-5 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21163slr005ltr.pdf
07/09/2002 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

06/26/2001 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/13/2001 SUPPL-2 Manufacturing (CMC)-Formulation

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/17/2016 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021163s032,021559s025lbl.pdf
09/17/2004 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21163s011lbl.pdf
05/18/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21163lbl.pdf

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