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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021265
Company: SANDOZ CANADA INC

Products on NDA 021265

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
INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE)	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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021265

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.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/06/2024	SUPPL-44	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021163Orig1s045;021265Orig1s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021163Orig1s045; 021265Orig1s044ltr.pdf
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

Labels for NDA 021265

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/06/2024	SUPPL-44	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021163Orig1s045;021265Orig1s044lbl.pdf
11/06/2024	SUPPL-44	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021163Orig1s045;021265Orig1s044lbl.pdf
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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