Siklos
These highlights do not include all the information needed to use SIKLOS safely and effectively. See full prescribing information for SIKLOS. SIKLOS (hydroxyurea) tablets, for oral use Initial U.S. Approval: 1967
Approved
Approval ID
76957c0d-0f98-4376-bb06-eee651adc09d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 4, 2024
Manufacturers
FDA
Medunik
DUNS: 080318531
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
hydroxyurea
PRODUCT DETAILS
NDC Product Code71770-105
Application NumberNDA208843
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateNovember 4, 2023
Generic Namehydroxyurea
INGREDIENTS (6)
hydroxyureaActive
Quantity: 100 mg in 1 1
Code: X6Q56QN5QC
Classification: ACTIB
Microcrystalline CelluloseInactive
Code: OP1R32D61U
Classification: IACT
Silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Sodium stearyl fumarateInactive
Code: 7CV7WJK4UI
Classification: IACT
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMERInactive
Code: 905HNO1SIH
Classification: IACT
Isopropyl alcoholInactive
Code: ND2M416302
Classification: IACT
hydroxyurea
PRODUCT DETAILS
NDC Product Code71770-120
Application NumberNDA208843
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateNovember 4, 2023
Generic Namehydroxyurea
INGREDIENTS (6)
hydroxyureaActive
Quantity: 1000 mg in 1 1
Code: X6Q56QN5QC
Classification: ACTIB
Microcrystalline CelluloseInactive
Code: OP1R32D61U
Classification: IACT
Silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Sodium stearyl fumarateInactive
Code: 7CV7WJK4UI
Classification: IACT
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMERInactive
Code: 905HNO1SIH
Classification: IACT
Isopropyl alcoholInactive
Code: ND2M416302
Classification: IACT