FINACEA FOAM
These highlights do not include all the information needed to use FINACEA Foam safely and effectively. See full prescribing information for FINACEA Foam. FINACEA (azelaic acid) foam, for topical use Initial U.S. Approval: 1995
Approved
Approval ID
9fabd24e-4c3b-49a0-aa5f-c8d75ae67572
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 8, 2020
Manufacturers
FDA
LEO Pharma Inc.
DUNS: 832692615
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
azelaic acid
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50222-303
Application NumberNDA207071
Product Classification
M
Marketing Category
C73594
G
Generic Name
azelaic acid
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 8, 2020
FDA Product Classification
INGREDIENTS (13)
AZELAIC ACIDActive
Quantity: .15 g in 1 g
Code: F2VW3D43YT
Classification: ACTIB
BENZOIC ACIDInactive
Code: 8SKN0B0MIM
Classification: IACT
GLYCERYL MONO AND DIPALMITOSTEARATEInactive
Code: KC98RO82HJ
Classification: IACT
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
METHYLCELLULOSE (4000 MPA.S)Inactive
Code: MRJ667KA5E
Classification: IACT
DIMETHYL ISOSORBIDEInactive
Code: SA6A6V432S
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
POLYOXYL 40 STEARATEInactive
Code: 13A4J4NH9I
Classification: IACT