FDA.reportPublic FDA data

Application 021265

Type
NDA
Sponsor
SANDOZ CANADA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001INFUVITE PEDIATRICASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; TOCOPHEROL ACETATE; VITAMIN A; VITAMIN KINJECTABLE;INTRAVENOUS80MG/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/VIALYesYes
002INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE)ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; TOCOPHEROL HYDROCHLORIDE; VITAMIN A; VITAMIN KINJECTABLE;INTRAVENOUS80MG/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/VIALYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021265-001INFUVITE PEDIATRICASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; TOCOPHEROL ACETATE; VITAMIN A; VITAMIN K80MG/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/VIALINJECTABLE / INTRAVENOUSAPRLD, RS2001-02-21
N021265-002INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE)ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; TOCOPHEROL ACETATE; VITAMIN A; VITAMIN K80MG/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/VIALINJECTABLE / INTRAVENOUSAPRLD, RS2004-01-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
N021265-001AP
N021265-002AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 3 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09N021265-001INFUVITE PEDIATRIC80MG/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/VIALINJECTABLE / INTRAVENOUSRLD, RS2001-02-21e64feba35796…
2022-09-29 23:25 UTC2022-09N021265-002INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE)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/VIALINJECTABLE / INTRAVENOUSRLD, RS2004-01-29e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021265-001INFUVITE PEDIATRIC80MG/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/VIALINJECTABLE / INTRAVENOUSRLD, RS2001-02-21cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021265-002INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE)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/VIALINJECTABLE / INTRAVENOUSRLD, RS2004-01-29cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021265-001INFUVITE PEDIATRIC80MG/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/VIALINJECTABLE / INTRAVENOUSAPRLD, RS2001-02-21a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021265-002INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE)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/VIALINJECTABLE / INTRAVENOUSAPRLD, RS2004-01-29a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09N021265-001AP1c2088c7a36db…
2026-10-15 13:18:302026-09N021265-002AP1c2088c7a36db…
2026-09-14 22:38:342026-08N021265-001AP184e616aacf4f…
2026-09-14 22:38:342026-08N021265-002AP184e616aacf4f…
2026-08-18 06:07:402026-07N021265-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N021265-002AP1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021265-001AP1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021265-002AP1a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pediatric Infuvite Multiple VitaminsASCORBIC ACID, VITAMIN A PALMITATE, CHOLECALCIFEROL, THIAMINE HYDROCHLORIDE, RIBOFLAVIN-5 PHOSPHATE SODIUM, PYRIDOXINE HYDROCHLORIDE, NIACINAMIDE, DEXPANTHENOL, ALPHA-TOCOPHEROL ACETATE, VITAMIN K1, FOLIC ACID, BIOTIN, CYANOCOBALAMINSandoz Inc4ff223f7-e076-4e81-8151-5c06724fabd92025-08-18Warnings, Adverse reactionsExact identifier
application applno (NDA): 021265
application number: NDA021265
ndc (product): 54643-9023
Infuvite PediatricMULTIPLE VITAMINS INJECTIONSandoz Inc6d06546e-8b0a-4490-82d9-397bd902a0442024-11-20Warnings, Adverse reactionsExact identifier
application applno (NDA): 021265
application number: NDA021265
ndc (product): 54643-5646

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
54643-5646Pediatric Infuvite Multiple Vitamins for InfusionAsorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin 5-phosphate sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol acetate, Vitamin K1, FoSandoz Canada IncNDACurrent
54643-5646PEDIATRIC INFUVITE MULTIPLE VITAMINS FOR INFUSIONascorbic acid, vitamin a palmitate, cholecalciferol, thiamine hydrochloride, riboflavin 5-phosphate sodium, pyridoxine hydrochloride, niacinamide, dexpanthenol, alpha-tocopherol acetate, vitamin k1, folic acid, biotin, cyanocobalaminSandoz IncNDACurrent
54643-5646PEDIATRIC INFUVITE MULTIPLE VITAMINS FOR INFUSIONascorbic acid, vitamin a palmitate, cholecalciferol, thiamine hydrochloride, riboflavin 5-phosphate sodium, pyridoxine hydrochloride, niacinamide, dexpanthenol, alpha-tocopherol acetate, vitamin k1, folic acid, biotin, cyanocobalaminSandoz IncNDACurrent
54643-5646PEDIATRIC INFUVITE MULTIPLE VITAMINS FOR INFUSIONascorbic acid, vitamin a palmitate, cholecalciferol, thiamine hydrochloride, riboflavin 5-phosphate sodium, pyridoxine hydrochloride, niacinamide, dexpanthenol, alpha-tocopherol acetate, vitamin k1, folic acid, biotin, cyanocobalaminSandoz Manufacturing IncNDACurrent
54643-7886Pediatric Infuvite Multiple VitaminsAscorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin-5 phosphate sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol acetate, Vitamin K1, Folic Acid, Biotin, CyanocobalaminSandoz IncNDACurrent
54643-7886Pediatric Infuvite Multiple VitaminsAscorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin-5 phosphate sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol acetate, Vitamin K1, Folic Acid, Biotin, CyanocobalaminSandoz IncNDACurrent
54643-7886Pediatric Infuvite Multiple VitaminsAscorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin-5 phosphate sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol acetate, Vitamin K1, Folic Acid, Biotin, CyanocobalaminSandoz IncNDACurrent
54643-7886Pediatric Infuvite Multiple VitaminsAscorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin-5 phosphate sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol acetate, Vitamin K1, Folic Acid, Biotin, CyanocobalaminSandoz Manufacturing IncNDACurrent
54643-9023Pediatric Infuvite Multiple VitaminsAscorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin-5 phosphate sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol acetate, Vitamin K1, Folic Acid, Biotin, CyanocobalaminSandoz IncNDACurrent
54643-9023Pediatric Infuvite Multiple VitaminsAscorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin-5 phosphate sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol acetate, Vitamin K1, Folic Acid, Biotin, CyanocobalaminSandoz IncNDACurrent
54643-9023Pediatric Infuvite Multiple VitaminsAscorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin-5 phosphate sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol acetate, Vitamin K1, Folic Acid, Biotin, CyanocobalaminSandoz IncNDACurrent
54643-9023Pediatric Infuvite Multiple VitaminsAscorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin-5 phosphate sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol acetate, Vitamin K1, Folic Acid, Biotin, CyanocobalaminSandoz Manufacturing IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80178SUPPL 2025-02-04
80179SUPPL 2024-11-07
36505SUPPL2016-03-22
4827SUPPL2016-03-21
14783SUPPL2009-01-02
27264SUPPL2008-12-23
4826SUPPL2004-06-07
14782SUPPL2003-05-02
36504ORIG2001-02-21
21555ORIG2001-02-21
4825ORIG2001-02-21