Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021265
Company: SANDOZ INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INFUVITE PEDIATRIC ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; TOCOPHEROL ACETATE; VITAMIN A; VITAMIN K 80MG/VIAL;0.02MG/VIAL;400 IU/VIAL;0.001MG/VIAL;5MG/VIAL;0.14MG/VIAL;17MG/VIAL;1MG/VIAL;1.4MG/VIAL;1.2MG/VIAL;7 IU/VIAL;2,300 IU/VIAL;0.2MG/VIAL INJECTABLE;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
02/21/2001 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-265_Infuvite%20Pediatric_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-265_Infuvite%20Pediatric_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-265_Infuvite.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/02/2015 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

03/17/2016 SUPPL-30 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021265s030,021646s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021265Orig1s030,021646Orig1s022ltr.pdf
11/11/2014 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

09/04/2014 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

12/17/2008 SUPPL-15 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021265s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021265s015ltr.pdf
08/22/2006 SUPPL-13 Labeling-Container/Carton Labels

Label is not available on this site.

02/12/2003 SUPPL-5 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21265slr005ltr.pdf
07/10/2002 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

07/09/2002 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

06/26/2001 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

10/03/2001 SUPPL-1 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21265s1lbl.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/17/2016 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021265s030,021646s022lbl.pdf
12/17/2008 SUPPL-15 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021265s015lbl.pdf
12/17/2008 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021265s015lbl.pdf
10/03/2001 SUPPL-1 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21265s1lbl.pdf
02/21/2001 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-265_Infuvite%20Pediatric_prntlbl.pdf

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