Finacea
Approved
Approval ID
6c5e836c-2851-4524-b91d-12ffadffd9ba
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 31, 2010
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 Code54868-5236
Application NumberNDA021470
Product Classification
M
Marketing Category
C73594
G
Generic Name
azelaic acid
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 31, 2010
FDA Product Classification
INGREDIENTS (8)
AZELAIC ACIDActive
Quantity: 0.15 g in 1 g
Code: F2VW3D43YT
Classification: ACTIB
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
BENZOIC ACIDInactive
Code: 8SKN0B0MIM
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT