MedPath

Differin

Approved
Approval ID

fb57f9d4-54d6-412c-aeb4-00a8bd46f958

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 21, 2011

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.

adapalene

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54868-5271
Application NumberNDA020748
Product Classification
M
Marketing Category
C73594
G
Generic Name
adapalene
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 21, 2011
FDA Product Classification

INGREDIENTS (8)

GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
ADAPALENEActive
Quantity: 1 mg in 1 g
Code: 1L4806J2QF
Classification: ACTIB
SQUALANEInactive
Code: GW89575KF9
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TROLAMINEInactive
Code: 9O3K93S3TK
Classification: IACT

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Differin - FDA Drug Approval Details