Adapalene
ADAPALENE CREAM 0.1%
Approved
Approval ID
276f7cce-5f54-40f8-8321-9192d0e52a73
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 18, 2021
Manufacturers
FDA
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
DUNS: 043838424
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 Code0168-0424
Application NumberANDA090824
Product Classification
M
Marketing Category
C73584
G
Generic Name
adapalene
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 22, 2018
FDA Product Classification
INGREDIENTS (11)
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)Inactive
Code: Z135WT9208
Classification: IACT
ADAPALENEActive
Quantity: 1 mg in 1 g
Code: 1L4806J2QF
Classification: ACTIB
CYCLOMETHICONEInactive
Code: NMQ347994Z
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SQUALENEInactive
Code: 7QWM220FJH
Classification: IACT
TROLAMINEInactive
Code: 9O3K93S3TK
Classification: IACT