ciclopirox
Ciclopirox Gel 0.77%
Approved
Approval ID
3c22416e-4293-4ba5-a983-137cbc6022db
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 13, 2017
Manufacturers
FDA
Glenmark Pharmaceuticals Inc., USA
DUNS: 130597813
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 Code68462-455
Application NumberANDA091595
Product Classification
M
Marketing Category
C73584
G
Generic Name
ciclopirox
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 13, 2017
FDA Product Classification
INGREDIENTS (7)
CICLOPIROXActive
Quantity: 7.7 mg in 1 g
Code: 19W019ZDRJ
Classification: ACTIB
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: 4Q93RCW27E
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT