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FDA Approval

Folcyteine

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 14, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Calcium citrate(47 mg in 1 1)
Folic acid(1000 ug in 1 1)
Vitamin D3(800 [iU] in 1 1)
Acetylcysteine(200 mg in 1 1)
Magnesium citrate(16 mg in 1 1)

Products1

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

Folcyteine

Product Details

NDC Product Code
59088-795
Route of Administration
ORAL
Effective Date
September 14, 2023
Code: MLM29U2X85Class: ACTIRQuantity: 47 mg in 1 1
Code: 935E97BOY8Class: ACTIBQuantity: 1000 ug in 1 1
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
Code: 1C6V77QF41Class: ACTIBQuantity: 800 [iU] in 1 1
Code: WYQ7N0BPYCClass: ACTIBQuantity: 200 mg in 1 1
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4DClass: IACT
Code: RHO26O1T9VClass: ACTIBQuantity: 16 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
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