azelaic acid
These highlights do not include all the information needed to use AZELAIC ACID GEL safely and effectively. See full prescribing information for AZELAIC ACID GEL.AZELAIC ACID Gel, for topical useInitial U.S. Approval: 1995
Approved
Approval ID
0b5ab22e-c78a-4429-9a76-a4ba2d11fcde
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 23, 2021
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.
azelaic acid
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68462-626
Application NumberANDA204637
Product Classification
M
Marketing Category
C73584
G
Generic Name
azelaic acid
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 23, 2021
FDA Product Classification
INGREDIENTS (9)
AZELAIC ACIDActive
Quantity: 0.15 g in 1 g
Code: F2VW3D43YT
Classification: ACTIB
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: 4Q93RCW27E
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
BENZOIC ACIDInactive
Code: 8SKN0B0MIM
Classification: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT