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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021163
Company: SANDOZ CANADA INC

Products on NDA 021163

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
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;30MCG/ML	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021163

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.

Labels for NDA 021163

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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