Finacea
These highlights do not include all the information needed to use FINACEA Gel safely and effectively. See full prescribing information for FINACEA Gel. FINACEA (azelaic acid) gel, for topical use Initial U.S. Approval: 1995
Approved
Approval ID
89ab8a10-bead-465c-9f24-02afa5aaec3c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 6, 2023
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
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 Code50090-4473
Application NumberNDA021470
Product Classification
M
Marketing Category
C73594
G
Generic Name
azelaic acid
Product Specifications
Route of AdministrationTOPICAL
Effective DateNovember 5, 2021
FDA Product Classification
INGREDIENTS (10)
BENZOIC ACIDInactive
Code: 8SKN0B0MIM
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
AZELAIC ACIDActive
Quantity: 0.15 g in 1 g
Code: F2VW3D43YT
Classification: ACTIB
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
1,2-DIARACHIDOYL-SN-GLYCERO-3-PHOSPHOCHOLINEInactive
Code: HE0P2D9ZLS
Classification: IACT
POLYACRYLIC ACID (250000 MW)Inactive
Code: 9G2MAD7J6W
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT