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FDA Approval

PureVit DualFe Plus

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

FDA Approval Summary

Company
PureTek Corporation
DUNS: 785961046
Effective Date
January 11, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Cupric sulfate(0.8 mg in 1 1)
Ferrous fumarate(53 mg in 1 1)
Iron Dextran(53 mg in 1 1)
Nicotinamide(30 mg in 1 1)
Pantothenic acid(10 mg in 1 1)
Pyridoxine(5 mg in 1 1)
Folic acid(1 mg in 1 1)
Vitamin B12(15 ug in 1 1)
Sodium ascorbate(200 mg in 1 1)
Thiamine(10 mg in 1 1)
Zinc sulfate(18.2 mg in 1 1)
Manganese sulfate(1.3 mg in 1 1)
Riboflavin(6 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

PureTek Corporation

PureTek Corporation

785961046

Products1

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

PureVit DualFe Plus

Product Details

NDC Product Code
59088-112
Route of Administration
ORAL
Effective Date
January 11, 2023
Code: LRX7AJ16DTClass: ACTIMQuantity: 0.8 mg in 1 1
Code: R5L488RY0QClass: ACTIMQuantity: 53 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1MClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
Code: 95HR524N2MClass: ACTIMQuantity: 53 mg in 1 1
Code: 25X51I8RD4Class: ACTIBQuantity: 30 mg in 1 1
Code: 568ET80C3DClass: ACTIMQuantity: 10 mg in 1 1
Code: 68Y4CF58BVClass: ACTIMQuantity: 5 mg in 1 1
Code: 935E97BOY8Class: ACTIBQuantity: 1 mg in 1 1
Code: P6YC3EG204Class: ACTIBQuantity: 15 ug in 1 1
Code: S033EH8359Class: ACTIMQuantity: 200 mg in 1 1
ThiamineActive
Code: 8K0I04919XClass: ACTIRQuantity: 10 mg in 1 1
Code: 89DS0H96TBClass: ACTIMQuantity: 18.2 mg in 1 1
Code: W00LYS4T26Class: ACTIMQuantity: 1.3 mg in 1 1
Code: TLM2976OFRClass: ACTIBQuantity: 6 mg in 1 1
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