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FDA Approval

Multivitamin with Fluoride

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

FDA Approval Summary

Company
PureTek Corporation
DUNS: 785961046
Effective Date
September 2, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Sodium fluoride(0.5 mg in 1 1)
Vitamin A(750 ug in 1 1)
Sodium ascorbate(36 mg in 1 1)
Vitamin C(24 mg in 1 1)
Riboflavin(1.2 mg in 1 1)
Thiamine(1.05 mg in 1 1)
Folic acid(300 ug in 1 1)
Pyridoxine(1.05 mg in 1 1)
Vitamin B12(4.5 ug in 1 1)
Vitamin D3(10 ug in 1 1)
Nicotinamide(13.5 mg in 1 1)

Products1

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

Multivitamin with Fluoride

Product Details

NDC Product Code
59088-108
Route of Administration
ORAL
Effective Date
September 2, 2022
SUCROSEInactive
Code: C151H8M554Class: IACT
D&C RED NO. 27Inactive
Code: 2LRS185U6KClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
Code: 8ZYQ1474W7Class: ACTIMQuantity: 0.5 mg in 1 1
Vitamin AActive
Code: 81G40H8B0TClass: ACTIBQuantity: 750 ug in 1 1
Code: S033EH8359Class: ACTIMQuantity: 36 mg in 1 1
Vitamin CActive
Code: PQ6CK8PD0RClass: ACTIBQuantity: 24 mg in 1 1
Code: TLM2976OFRClass: ACTIBQuantity: 1.2 mg in 1 1
ThiamineActive
Code: 8K0I04919XClass: ACTIRQuantity: 1.05 mg in 1 1
Code: 935E97BOY8Class: ACTIBQuantity: 300 ug in 1 1
Code: 68Y4CF58BVClass: ACTIMQuantity: 1.05 mg in 1 1
Code: P6YC3EG204Class: ACTIBQuantity: 4.5 ug in 1 1
ASPARTAMEInactive
Code: Z0H242BBR1Class: IACT
Code: 1C6V77QF41Class: ACTIBQuantity: 10 ug in 1 1
Code: 25X51I8RD4Class: ACTIBQuantity: 13.5 mg in 1 1
Code: WR1WPI7EW8Class: ACTIMQuantity: 10 mg in 1 1
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