Ciclopirox
Ciclopirox Topical Solution, 8% (Nail Lacquer)
Approved
Approval ID
9144c51a-5a76-43b9-958d-c0d9fd4269e5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 13, 2019
Manufacturers
FDA
Taro Pharmaceuticals U.S.A., Inc.
DUNS: 145186370
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 Code51672-5302
Application NumberANDA078233
Product Classification
M
Marketing Category
C73584
G
Generic Name
ciclopirox
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 4, 2019
FDA Product Classification
INGREDIENTS (3)
ciclopiroxActive
Quantity: 80 mg in 1 mL
Code: 19W019ZDRJ
Classification: ACTIB
Ethyl AcetateInactive
Code: 76845O8NMZ
Classification: IACT
Isopropyl AcetateInactive
Code: 1Y67AFK870
Classification: IACT