Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021265
Company: SANDOZ CANADA INC
Company: SANDOZ CANADA 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 |
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 |
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 |
---|---|---|---|---|---|
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 |
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 |