CNL8
CNL8 (ciclopirox topical solution 8%)Nail Lacquer
Approved
Approval ID
68955ba2-590f-4460-994e-bc481aed3d23
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 1, 2011
Manufacturers
FDA
Innocutis Holdings LLC
DUNS: 071501252
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 Code68712-027
Application NumberANDA078270
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ciclopirox
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 1, 2011
FDA Product Classification
INGREDIENTS (3)
CICLOPIROXActive
Quantity: 2.28 g in 1 mL
Code: 19W019ZDRJ
Classification: ACTIB
ETHYL ACETATEInactive
Code: 76845O8NMZ
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT