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FDA Approval

Folixapure

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
Folic acid(1 mg in 1 1)
Vitamin D3(125 ug in 1 1)

Products1

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

Folixapure

Product Details

NDC Product Code
59088-163
Route of Administration
ORAL
Effective Date
January 11, 2023
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6BClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
Code: 935E97BOY8Class: ACTIBQuantity: 1 mg in 1 1
Code: 9VU1KI44GPClass: ACTIBQuantity: 125 ug in 1 1
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