AZELEX
AZELEX® (azelaic acid cream) 20%
Approved
Approval ID
0d5269d5-6555-4d2c-bc3b-df862b014275
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 11, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-4442
Application NumberNDA020428
Product Classification
M
Marketing Category
C73594
G
Generic Name
azelaic acid
Product Specifications
Route of AdministrationCUTANEOUS
Effective DateJune 11, 2012
FDA Product Classification
INGREDIENTS (10)
azelaic acidActive
Quantity: 0.2 g in 1 g
Code: F2VW3D43YT
Classification: ACTIB
cetearyl ethylhexanoateInactive
Code: 9M64UO4C25
Classification: IACT
cetyl palmitateInactive
Code: 5ZA2S6B08X
Classification: IACT
glycerinInactive
Code: PDC6A3C0OX
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
cetostearyl alcoholInactive
Code: 2DMT128M1S
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
glyceryl monostearateInactive
Code: 230OU9XXE4
Classification: IACT
coco-glyceridesInactive
Code: ISE9I7DNUG
Classification: IACT
benzoic acidInactive
Code: 8SKN0B0MIM
Classification: IACT