Ciclopirox
Ciclopirox Topical Solution, 8% (Nail Lacquer)
Approved
Approval ID
4439cb3d-6825-4558-a981-122ec15f7b05
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 12, 2022
Manufacturers
FDA
Akorn
DUNS: 117696873
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ciclopirox
PRODUCT DETAILS
NDC Product Code50383-419
Application NumberANDA078270
Marketing CategoryC73584
Route of AdministrationTOPICAL
Effective DateMay 26, 2022
Generic NameCiclopirox
INGREDIENTS (4)
ETHYL ACETATEInactive
Code: 76845O8NMZ
Classification: IACT
CICLOPIROXActive
Quantity: 71.3 mg in 1 mL
Code: 19W019ZDRJ
Classification: ACTIB
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
MALEIC ACIDInactive
Code: 91XW058U2C
Classification: IACT