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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50383-419
Application NumberANDA078270
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ciclopirox
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 26, 2022
FDA Product Classification
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