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FDA Approval

Keylosa

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

FDA Approval Summary

Company
Novian Pharmaceuticals
DUNS: 100278361
Effective Date
October 6, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Vitamin D3(20 ug in 1 1)
Vitamin A(1500 ug in 1 1)
Folic acid(1000 ug in 1 1)
Manganese sulfate(23 mg in 1 1)
Vitamin C(120 mg in 1 1)
Chromium(35 ug in 1 1)
Riboflavin(3.4 mg in 1 1)
Pyridoxine(20 mg in 1 1)
Magnesium oxide(200 mg in 1 1)
Zinc oxide(25 mg in 1 1)
Molybdenum(45 ug in 1 1)
Vitamin B12(8 ug in 1 1)
Ferrous fumarate(27 mg in 1 1)
Selenious acid(55 ug in 1 1)
Thiamine(3 mg in 1 1)
Calcium carbonate(200 mg in 1 1)
Nicotinamide(20 mg in 1 1)
Tocopherol(30 mg in 1 1)

Products1

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

Keylosa

Product Details

NDC Product Code
83146-003
Route of Administration
ORAL
Effective Date
October 6, 2023
Code: 1C6V77QF41Class: ACTIBQuantity: 20 ug in 1 1
Vitamin AActive
Code: 81G40H8B0TClass: ACTIBQuantity: 1500 ug in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
Code: 935E97BOY8Class: ACTIBQuantity: 1000 ug in 1 1
Code: W00LYS4T26Class: ACTIMQuantity: 23 mg in 1 1
Vitamin CActive
Code: PQ6CK8PD0RClass: ACTIBQuantity: 120 mg in 1 1
ChromiumActive
Code: 0R0008Q3JBClass: ACTIBQuantity: 35 ug in 1 1
Code: TLM2976OFRClass: ACTIBQuantity: 3.4 mg in 1 1
Code: KV2JZ1BI6ZClass: ACTIBQuantity: 20 mg in 1 1
Code: 3A3U0GI71GClass: ACTIMQuantity: 200 mg in 1 1
Code: SOI2LOH54ZClass: ACTIBQuantity: 25 mg in 1 1
Code: 81AH48963UClass: ACTIBQuantity: 45 ug in 1 1
Code: P6YC3EG204Class: ACTIBQuantity: 8 ug in 1 1
Code: R5L488RY0QClass: ACTIMQuantity: 27 mg in 1 1
Code: H6241UJ22BClass: ACTIBQuantity: 55 ug in 1 1
ThiamineActive
Code: 8K0I04919XClass: ACTIRQuantity: 3 mg in 1 1
Code: H0G9379FGKClass: ACTIMQuantity: 200 mg in 1 1
Code: 25X51I8RD4Class: ACTIBQuantity: 20 mg in 1 1
Code: H4N855PNZ1Class: ACTIBQuantity: 30 mg in 1 1
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