CICLOPIROX

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

Company

DUNS: 956741896

Effective Date

November 12, 2014

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Ciclopirox(80 mg in 1 mL)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

61748-200

Application Number

ANDA078975

Marketing Category

ANDA (C73584)

Route of Administration

TOPICAL

Effective Date

November 12, 2014

Ingredients

Code: 19W019ZDRJClass: ACTIBQuantity: 80 mg in 1 mL

ISOPROPYL ALCOHOLInactive

Code: ND2M416302Class: IACT

ETHYL ACETATEInactive

Code: 76845O8NMZClass: IACT

BUTYL ESTER OF METHYL VINYL ETHER/MALEIC ANHYDRIDE COPOLYMER (125000 MW)Inactive

Code: 389H2R62BDClass: IACT