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FDA Approval

Ciclopirox

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

FDA Approval Summary

Company
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
DUNS: 043838424
Effective Date
October 15, 2013
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Ciclopirox(7.70 mg in 1 g)

Products1

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

Ciclopirox

Product Details

NDC Product Code
0168-0407
Application Number
ANDA077896
Marketing Category
ANDA (C73584)
Route of Administration
TOPICAL
Effective Date
October 15, 2013
Code: 19W019ZDRJClass: ACTIBQuantity: 7.70 mg in 1 g
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
OCTYLDODECANOLInactive
Code: 461N1O614YClass: IACT
PEG/PPG-18/18 DIMETHICONEInactive
Code: 9H0AO7T794Class: IACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: 4Q93RCW27EClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0Class: IACT
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