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.

NDC Product Code21695-475

Application NumberANDA078270

Marketing CategoryC73584

Route of AdministrationTOPICAL

Effective DateOctober 9, 2009

Generic NameCiclopirox

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