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FDA Approval

Adult 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(200 mg in 10 mL)
Palmitic Acid(3300 [iU] in 10 mL)
Vitamin D3(200 [iU] in 10 mL)
Thiamine(6 mg in 10 mL)
Pyridoxine(6 mg in 10 mL)
Nicotinamide(40 mg in 10 mL)
Dexpanthenol(15 mg in 10 mL)
Vitamin K1(150 ug in 10 mL)
Folic acid(600 ug in 10 mL)
Vitamin B12(5 ug in 10 mL)
Biotin(60 ug in 10 mL)
alpha-Tocopherol acetate(10 [iU] in 10 mL)

Products2

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

Adult Infuvite Multiple Vitamins

Product Details

NDC Product Code
54643-9007
Application Number
NDA021163
Marketing Category
NDA (C73594)
Route of Administration
INTRAVENOUS
Effective Date
October 28, 2016
Vitamin CActive
Code: PQ6CK8PD0RClass: ACTIBQuantity: 200 mg in 10 mL
Code: 1D1K0N0VVCClass: ACTIMQuantity: 3300 [iU] in 10 mL
Code: 1C6V77QF41Class: ACTIBQuantity: 200 [iU] in 10 mL
ThiamineActive
Code: M572600E5PClass: ACTIRQuantity: 6 mg in 10 mL
Code: 68Y4CF58BVClass: ACTIBQuantity: 6 mg in 10 mL
Code: 20RD1DZH99Class: ACTIMQuantity: 3.6 mg in 10 mL
Code: 25X51I8RD4Class: ACTIBQuantity: 40 mg in 10 mL
Code: 1O6C93RI7ZClass: ACTIBQuantity: 15 mg in 10 mL
Code: A034SE7857Class: ACTIBQuantity: 150 ug in 10 mL
Code: 935E97BOY8Class: ACTIBQuantity: 600 ug in 10 mL
Code: P6YC3EG204Class: ACTIBQuantity: 5 ug in 10 mL
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
BiotinActive
Code: 6SO6U10H04Class: ACTIBQuantity: 60 ug in 10 mL
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULRClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
Code: 9E8X80D2L0Class: ACTIBQuantity: 10 [iU] in 10 mL

Adult Infuvite Multiple Vitamins

Product Details

NDC Product Code
54643-9015
Application Number
NDA021559
Marketing Category
NDA (C73594)
Route of Administration
INTRAVENOUS
Effective Date
October 28, 2016
Code: 1D1K0N0VVCClass: ACTIMQuantity: 3300 [iU] in 10 mL
Vitamin CActive
Code: PQ6CK8PD0RClass: ACTIBQuantity: 200 mg in 10 mL
Code: 1C6V77QF41Class: ACTIBQuantity: 200 [iU] in 10 mL
ThiamineActive
Code: M572600E5PClass: ACTIRQuantity: 6 mg in 10 mL
Code: 20RD1DZH99Class: ACTIMQuantity: 3.6 mg in 10 mL
Code: A034SE7857Class: ACTIBQuantity: 150 ug in 10 mL
Code: 68Y4CF58BVClass: ACTIBQuantity: 6 mg in 10 mL
Code: 25X51I8RD4Class: ACTIBQuantity: 40 mg in 10 mL
Code: 1O6C93RI7ZClass: ACTIBQuantity: 15 mg in 10 mL
BiotinActive
Code: 6SO6U10H04Class: ACTIBQuantity: 60 ug in 10 mL
Code: P6YC3EG204Class: ACTIBQuantity: 5 ug in 10 mL
Code: 935E97BOY8Class: ACTIBQuantity: 600 ug in 10 mL
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULRClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
Code: 9E8X80D2L0Class: ACTIBQuantity: 10 [iU] in 10 mL
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