Ciclodan
Ciclodan Ciclopirox Topical Solution, 8% (Nail Lacquer)
Approved
Approval ID
246676e5-60a0-41dc-b665-30d5e670b426
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 21, 2020
Manufacturers
FDA
Medimetriks Pharmaceuticals, Inc.
DUNS: 019903816
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 Code43538-500
Application NumberANDA078233
Product Classification
M
Marketing Category
C73584
G
Generic Name
ciclopirox
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 21, 2020
FDA Product Classification
INGREDIENTS (4)
ciclopiroxActive
Quantity: 2.28 g in 1 mL
Code: 19W019ZDRJ
Classification: ACTIB
ethyl acetateInactive
Code: 76845O8NMZ
Classification: IACT
isopropyl alcoholInactive
Code: ND2M416302
Classification: IACT
butyl ester of methyl vinyl ether/maleic anhydride copolymer (125000 mw)Inactive
Code: 389H2R62BD
Classification: IACT