MedPath

Triamcinolone Acetonide

Triamcinolone Acetonide Ointment USP,  0.5% For Dermatologic Use Only Not For Ophthalmic Use Rx Only

Approved
Approval ID

76d9b45a-9efd-efa3-00ad-d32a24ef0ff8

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 3, 2017

Manufacturers
FDA

Teligent Pharma, Inc.

DUNS: 011036910

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 Code52565-048
Application NumberANDA208590
Product Classification
M
Marketing Category
C73584
G
Generic Name
triamcinolone acetonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateOctober 7, 2021
FDA Product Classification

INGREDIENTS (3)

Light Mineral OilInactive
Code: N6K5787QVP
Classification: IACT
Triamcinolone AcetonideActive
Quantity: 5 mg in 1 g
Code: F446C597KA
Classification: ACTIB
PetrolatumInactive
Code: 4T6H12BN9U
Classification: IACT

MedPath

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

© 2025 MedPath, Inc. All rights reserved.

Triamcinolone Acetonide - FDA Drug Approval Details