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FDA Approval

Pediatric Infuvite Multiple Vitamins

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Sandoz Inc
DUNS: 005387188
Effective Date
October 28, 2016
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Vitamin C(80 mg in 5 mL)
Palmitic Acid(2300 [iU] in 5 mL)
Vitamin D3(400 [iU] in 5 mL)
Dexpanthenol(5 mg in 5 mL)
Thiamine(1.2 mg in 5 mL)
Vitamin K1(0.2 mg in 5 mL)
Pyridoxine(1 mg in 5 mL)
Nicotinamide(17 mg in 5 mL)
Folic acid(140 ug in 5 mL)
Biotin(20 ug in 5 mL)
Vitamin B12(1 ug in 5 mL)
alpha-Tocopherol acetate(7 [iU] in 5 mL)

Products2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Pediatric Infuvite Multiple Vitamins

Product Details

NDC Product Code
54643-9023
Application Number
NDA021265
Marketing Category
NDA (C73594)
Route of Administration
INTRAVENOUS
Effective Date
October 28, 2016
Vitamin CActive
Code: PQ6CK8PD0RClass: ACTIBQuantity: 80 mg in 5 mL
Code: 1D1K0N0VVCClass: ACTIMQuantity: 2300 [iU] in 5 mL
Code: 1C6V77QF41Class: ACTIBQuantity: 400 [iU] in 5 mL
Code: 20RD1DZH99Class: ACTIMQuantity: 1.4 mg in 5 mL
Code: 1O6C93RI7ZClass: ACTIBQuantity: 5 mg in 5 mL
ThiamineActive
Code: M572600E5PClass: ACTIRQuantity: 1.2 mg in 5 mL
Code: A034SE7857Class: ACTIBQuantity: 0.2 mg in 5 mL
Code: 68Y4CF58BVClass: ACTIBQuantity: 1 mg in 5 mL
Code: 25X51I8RD4Class: ACTIBQuantity: 17 mg in 5 mL
Code: 935E97BOY8Class: ACTIBQuantity: 140 ug in 5 mL
BiotinActive
Code: 6SO6U10H04Class: ACTIBQuantity: 20 ug in 5 mL
Code: P6YC3EG204Class: ACTIBQuantity: 1 ug in 5 mL
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACTQuantity: 50 mg in 5 mL
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULRClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACTQuantity: 75 mg in 5 mL
Code: 9E8X80D2L0Class: ACTIBQuantity: 7 [iU] in 5 mL

Pediatric Infuvite Multiple Vitamins

Product Details

NDC Product Code
54643-9031
Application Number
NDA021646
Marketing Category
NDA (C73594)
Effective Date
October 28, 2016
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