Adapalene
Adapalene Gel, 0.1%
Approved
Approval ID
69846bde-5f7e-4b40-8a67-fbd15d80cfbd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 25, 2021
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
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 Code50090-2004
Application NumberANDA091314
Product Classification
M
Marketing Category
C73584
G
Generic Name
Adapalene
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 25, 2021
FDA Product Classification
INGREDIENTS (8)
POLOXAMER 182Inactive
Code: JX0HIX6OAG
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
ADAPALENEActive
Quantity: 1 mg in 1 g
Code: 1L4806J2QF
Classification: ACTIB
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: 4Q93RCW27E
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT