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FDA Approval

Multi-Vitamin with Fluoride

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

FDA Approval Summary

Company
Effective Date
December 12, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Palmitic Acid(1500 [iU] in 1 mL)
Vitamin C(35 mg in 1 mL)
Vitamin D3(400 [iU] in 1 mL)
Thiamine(0.5 mg in 1 mL)
Vitamin B12(2 ug in 1 mL)
Nicotinamide(8 mg in 1 mL)
Pyridoxine(0.4 mg in 1 mL)
Sodium fluoride(0.5 mg in 1 mL)

Products1

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

Multi-Vitamin with Fluoride

Product Details

NDC Product Code
58657-326
Route of Administration
ORAL
Effective Date
December 12, 2023
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4Class: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
Code: 1D1K0N0VVCClass: ACTIMQuantity: 1500 [iU] in 1 mL
SORBITOLInactive
Code: 506T60A25RClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4Class: IACT
Vitamin CActive
Code: PQ6CK8PD0RClass: ACTIBQuantity: 35 mg in 1 mL
Code: 1C6V77QF41Class: ACTIBQuantity: 400 [iU] in 1 mL
ThiamineActive
Code: M572600E5PClass: ACTIRQuantity: 0.5 mg in 1 mL
Code: 20RD1DZH99Class: ACTIMQuantity: 0.6 mg in 1 mL
Code: P6YC3EG204Class: ACTIBQuantity: 2 ug in 1 mL
Code: 25X51I8RD4Class: ACTIBQuantity: 8 mg in 1 mL
Code: 68Y4CF58BVClass: ACTIBQuantity: 0.4 mg in 1 mL
Code: 8ZYQ1474W7Class: ACTIMQuantity: 0.5 mg in 1 mL
Code: LU4B53JYVEClass: ACTIBQuantity: 5 [iU] in 1 mL
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