Adapalene
Adapalene Gel, 0.1%
Approved
Approval ID
b85b6d8c-afbc-4ce1-9f77-e2579bf72c12
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 24, 2018
Manufacturers
FDA
PruGen, Inc.
DUNS: 929922750
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Adapalene
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42546-720
Application NumberANDA091314
Product Classification
M
Marketing Category
C73584
G
Generic Name
Adapalene
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 24, 2018
FDA Product Classification
INGREDIENTS (8)
ADAPALENEActive
Quantity: 45 g in 1 g
Code: 1L4806J2QF
Classification: ACTIB
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
CARBOXYPOLYMETHYLENEInactive
Code: 0A5MM307FC
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
POLOXAMER 182Inactive
Code: JX0HIX6OAG
Classification: IACT