Ciclopirox
Ciclopirox Topical Solution, 8% (Nail Lacquer)
Approved
Approval ID
ee775b56-0575-41e4-a948-c92a0bcd69b6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 9, 2009
Manufacturers
FDA
Rebel Distributors Corp.
DUNS: 118802834
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 Code21695-475
Application NumberANDA078270
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ciclopirox
Product Specifications
Route of AdministrationTOPICAL
Effective DateOctober 9, 2009
FDA Product Classification
INGREDIENTS (4)
CICLOPIROXActive
Quantity: 71.3 mg in 1 mL
Code: 19W019ZDRJ
Classification: ACTIB
ETHYL ACETATEInactive
Code: 76845O8NMZ
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
MALEIC ACIDInactive
Code: 91XW058U2C
Classification: IACT