MedPath
FDA Approval

Pediatric Infuvite Multiple Vitamins

October 28, 2016

HUMAN PRESCRIPTION DRUG LABEL

Vitamin C(80 mg in 5 mL)
Palmitic Acid(2300 [iU] in 5 mL)
Dexpanthenol(5 mg in 5 mL)
Biotin(20 ug in 5 mL)
Vitamin D3(400 [iU] in 5 mL)
Thiamine(1.2 mg in 5 mL)
Pyridoxine(1 mg in 5 mL)
Nicotinamide(17 mg in 5 mL)
Vitamin K1(0.2 mg in 5 mL)
Folic acid(140 ug in 5 mL)
Vitamin B12(1 ug in 5 mL)
alpha-Tocopherol acetate(7 [iU] in 5 mL)

Products (2)

Pediatric Infuvite Multiple Vitamins

54643-7886

NDA021265

NDA (C73594)

INTRAVENOUS

October 28, 2016

Vitamin CActive
Code: PQ6CK8PD0RClass: ACTIBQuantity: 80 mg in 5 mL
Code: 1D1K0N0VVCClass: ACTIMQuantity: 2300 [iU] in 5 mL
Code: 20RD1DZH99Class: ACTIMQuantity: 1.4 mg in 5 mL
Code: 1O6C93RI7ZClass: ACTIBQuantity: 5 mg in 5 mL
BiotinActive
Code: 6SO6U10H04Class: ACTIBQuantity: 20 ug in 5 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACTQuantity: 75 mg in 5 mL
Code: 1C6V77QF41Class: ACTIBQuantity: 400 [iU] in 5 mL
ThiamineActive
Code: M572600E5PClass: ACTIRQuantity: 1.2 mg in 5 mL
Code: 68Y4CF58BVClass: ACTIBQuantity: 1 mg in 5 mL
Code: 25X51I8RD4Class: ACTIBQuantity: 17 mg in 5 mL
Code: A034SE7857Class: ACTIBQuantity: 0.2 mg in 5 mL
Code: 935E97BOY8Class: ACTIBQuantity: 140 ug in 5 mL
Code: P6YC3EG204Class: ACTIBQuantity: 1 ug in 5 mL
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACTQuantity: 50 mg in 5 mL
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULRClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
Code: 9E8X80D2L0Class: ACTIBQuantity: 7 [iU] in 5 mL

Pediatric Infuvite Multiple Vitamins

54643-7898

NDA021646

NDA (C73594)

October 28, 2016

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