Ciclopirox
Approved
Approval ID
5fa1e0b6-3836-4d56-99ee-0545908ee405
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 19, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ciclopirox
PRODUCT DETAILS
NDC Product Code54868-6064
Application NumberANDA078079
Marketing CategoryC73584
Route of AdministrationTOPICAL
Effective DateMay 19, 2010
Generic NameCiclopirox
INGREDIENTS (4)
ETHYL ACETATEInactive
Code: 76845O8NMZ
Classification: IACT
BUTYL ESTER OF METHYL VINYL ETHER-MALEIC ANHYDRIDE COPOLYMER (125 KD)Inactive
Code: 389H2R62BD
Classification: IACT
CICLOPIROXActive
Quantity: 80 mg in 1 mL
Code: 19W019ZDRJ
Classification: ACTIB
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT