Ciclopirox
CICLOPIROX TOPICAL SUSPENSION USP , 0.77% (w/w) (LOTION)
Approved
Approval ID
4aeae21c-8c03-4fa9-a191-6b1e9000cbdb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 15, 2014
Manufacturers
FDA
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
DUNS: 043838424
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 Code0168-0314
Application NumberANDA076422
Product Classification
M
Marketing Category
C73584
G
Generic Name
ciclopirox
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 15, 2014
FDA Product Classification
INGREDIENTS (12)
CICLOPIROX OLAMINEActive
Quantity: 7.7 mg in 1 mL
Code: 50MD4SB4AP
Classification: ACTIM
OCTYLDODECANOLInactive
Code: 461N1O614Y
Classification: IACT
COCO DIETHANOLAMIDEInactive
Code: 92005F972D
Classification: IACT
POLYSORBATE 60Inactive
Code: CAL22UVI4M
Classification: IACT
SORBITAN MONOSTEARATEInactive
Code: NVZ4I0H58X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
LACTIC ACIDInactive
Code: 33X04XA5AT
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
MYRISTYL ALCOHOLInactive
Code: V42034O9PU
Classification: IACT