MedPath

Kenalog

KENALOG SPRAY Triamcinolone Acetonide Topical Aerosol, USP (0.147 mg/g) Rx only For dermatologic use only Not for ophthalmic use

Approved
Approval ID

cdf6c80c-ddbd-498f-8897-3c0feebafe31

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 9, 2018

Manufacturers
FDA

Sun Pharmaceutical Industries, Inc.

DUNS: 146974886

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Triamcinolone Acetonide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code10631-093
Application NumberNDA012104
Product Classification
M
Marketing Category
C73594
G
Generic Name
Triamcinolone Acetonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateNovember 9, 2018
FDA Product Classification

INGREDIENTS (4)

TRIAMCINOLONE ACETONIDEActive
Quantity: 0.147 mg in 1 g
Code: F446C597KA
Classification: ACTIB
ISOPROPYL PALMITATEInactive
Code: 8CRQ2TH63M
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ISOBUTANEInactive
Code: BXR49TP611
Classification: IACT

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Kenalog - FDA Drug Approval Details