CICLOPIROX
Ciclopirox Topical Solution, 8% (Nail Lacquer)
Approved
Approval ID
5a562e2c-ac56-4e83-89b0-fe625e4c5e1d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 12, 2014
Manufacturers
FDA
VersaPharm Incorporated
DUNS: 956741896
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 Code61748-200
Application NumberANDA078975
Product Classification
M
Marketing Category
C73584
G
Generic Name
CICLOPIROX
Product Specifications
Route of AdministrationTOPICAL
Effective DateNovember 12, 2014
FDA Product Classification
INGREDIENTS (4)
CICLOPIROXActive
Quantity: 80 mg in 1 mL
Code: 19W019ZDRJ
Classification: ACTIB
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
ETHYL ACETATEInactive
Code: 76845O8NMZ
Classification: IACT
BUTYL ESTER OF METHYL VINYL ETHER/MALEIC ANHYDRIDE COPOLYMER (125000 MW)Inactive
Code: 389H2R62BD
Classification: IACT