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FDA Approval

Dialyvite Supreme D

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

FDA Approval Summary

Company
Hillestad Pharmaceuticals USA
DUNS: 029291085
Effective Date
October 14, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Pantothenic acid(10 mg in 1 1)
Biotin(300 ug in 1 1)
Zinc citrate(15 mg in 1 1)
Selenocysteine(70 ug in 1 1)
Vitamin D3(2000 [iU] in 1 1)
Thiamine(1.5 mg in 1 1)
Vitamin C(100 mg in 1 1)
Riboflavin(1.7 mg in 1 1)
Nicotinamide(20 mg in 1 1)
Pyridoxine(25 mg in 1 1)
Folic acid(3 mg in 1 1)
Vitamin B12(1 mg in 1 1)

Manufacturing Establishments1

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

Hillestad Pharmaceuticals USA

Hillestad Pharmaceuticals USA

029291085

Products1

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

Dialyvite Supreme D

Product Details

NDC Product Code
10542-009
Route of Administration
ORAL
Effective Date
October 24, 2019
Code: 568ET80C3DClass: ACTIMQuantity: 10 mg in 1 1
BiotinActive
Code: 6SO6U10H04Class: ACTIBQuantity: 300 ug in 1 1
Code: K72I3DEX9BClass: ACTIMQuantity: 15 mg in 1 1
Code: 0CH9049VISClass: ACTIMQuantity: 70 ug in 1 1
Calcium StearateInactive
Code: 776XM7047LClass: IACT
Code: 1C6V77QF41Class: ACTIBQuantity: 2000 [iU] in 1 1
ThiamineActive
Code: 8K0I04919XClass: ACTIRQuantity: 1.5 mg in 1 1
Vitamin CActive
Code: PQ6CK8PD0RClass: ACTIBQuantity: 100 mg in 1 1
Code: TLM2976OFRClass: ACTIBQuantity: 1.7 mg in 1 1
Code: 25X51I8RD4Class: ACTIBQuantity: 20 mg in 1 1
Code: 68Y4CF58BVClass: ACTIBQuantity: 25 mg in 1 1
Code: 935E97BOY8Class: ACTIBQuantity: 3 mg in 1 1
Code: 8406EY2OQAClass: ACTIBQuantity: 1 mg in 1 1
Microcrystalline CelluloseInactive
Code: OP1R32D61UClass: IACT
Croscarmellose SodiumInactive
Code: M28OL1HH48Class: IACT
Glyceryl MonostearateInactive
Code: 230OU9XXE4Class: IACT
ShellacInactive
Code: 46N107B71OClass: IACT
Starch, CornInactive
Code: O8232NY3SJClass: IACT
Silicon DioxideInactive
Code: ETJ7Z6XBU4Class: IACT
Sodium Copper ChlorophyllinInactive
Code: 1D276TYV9OClass: IACT
Code: LU4B53JYVEClass: ACTIMQuantity: 30 [iU] in 1 1
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