MedPath
FDA Product

Keylosa

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Keylosa

83146-003

Regulatory Information

83146-003

October 6, 2023

Keylosa

HUMAN PRESCRIPTION DRUG LABEL

1

Company Information

Novian Pharmaceuticals

100278361

Active Ingredients

CHOLECALCIFEROL

Quantity: 20 ug in 1 1

Code: 1C6V77QF41

Class Code: ACTIB

VITAMIN A

Quantity: 1500 ug in 1 1

Code: 81G40H8B0T

Class Code: ACTIB

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

FOLIC ACID

Quantity: 1000 ug in 1 1

Code: 935E97BOY8

Class Code: ACTIB

MANGANESE SULFATE

Quantity: 23 mg in 1 1

Code: W00LYS4T26

Class Code: ACTIM

ASCORBIC ACID

Quantity: 120 mg in 1 1

Code: PQ6CK8PD0R

Class Code: ACTIB

CHROMIUM

Quantity: 35 ug in 1 1

Code: 0R0008Q3JB

Class Code: ACTIB

RIBOFLAVIN

Quantity: 3.4 mg in 1 1

Code: TLM2976OFR

Class Code: ACTIB

PYRIDOXINE

Quantity: 20 mg in 1 1

Code: KV2JZ1BI6Z

Class Code: ACTIB

MAGNESIUM OXIDE

Quantity: 200 mg in 1 1

Code: 3A3U0GI71G

Class Code: ACTIM

ZINC OXIDE

Quantity: 25 mg in 1 1

Code: SOI2LOH54Z

Class Code: ACTIB

MOLYBDENUM

Quantity: 45 ug in 1 1

Code: 81AH48963U

Class Code: ACTIB

CYANOCOBALAMIN

Quantity: 8 ug in 1 1

Code: P6YC3EG204

Class Code: ACTIB

FERROUS FUMARATE

Quantity: 27 mg in 1 1

Code: R5L488RY0Q

Class Code: ACTIM

SELENIUM

Quantity: 55 ug in 1 1

Code: H6241UJ22B

Class Code: ACTIB

THIAMINE MONONITRATE

Quantity: 3 mg in 1 1

Code: 8K0I04919X

Class Code: ACTIR

CALCIUM CARBONATE

Quantity: 200 mg in 1 1

Code: H0G9379FGK

Class Code: ACTIM

NIACINAMIDE

Quantity: 20 mg in 1 1

Code: 25X51I8RD4

Class Code: ACTIB

.ALPHA.-TOCOPHEROL

Quantity: 30 mg in 1 1

Code: H4N855PNZ1

Class Code: ACTIB

Active Moieties

FOLIC ACID

Code: 935E97BOY8

MANGANOUS CATION

Code: H6EP7W5457

CHOLECALCIFEROL

Code: 1C6V77QF41

VITAMIN A

Code: 81G40H8B0T

ASCORBIC ACID

Code: PQ6CK8PD0R

SELENIUM

Code: H6241UJ22B

ZINC OXIDE

Code: SOI2LOH54Z

CYANOCOBALAMIN

Code: P6YC3EG204

CHROMIUM

Code: 0R0008Q3JB

RIBOFLAVIN

Code: TLM2976OFR

FERROUS CATION

Code: GW89581OWR

MAGNESIUM CATION

Code: T6V3LHY838

PYRIDOXINE

Code: KV2JZ1BI6Z

MOLYBDENUM

Code: 81AH48963U

.ALPHA.-TOCOPHEROL

Code: H4N855PNZ1

THIAMINE ION

Code: 4ABT0J945J

CALCIUM CATION

Code: 2M83C4R6ZB

NIACINAMIDE

Code: 25X51I8RD4

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