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Triamcinolone Acetonide

Triamcinolone Acetonide Cream USP, 0.025%, 0.1%, 0.5% Rx only

Approved
Approval ID

19099787-792e-465f-9cdb-a3132731dfc5

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 6, 2023

Manufacturers
FDA

Preferred Pharmaceuticals, Inc.

DUNS: 791119022

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 Code68788-7506
Application NumberANDA209535
Product Classification
M
Marketing Category
C73584
G
Generic Name
Triamcinolone Acetonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateOctober 6, 2023
FDA Product Classification

INGREDIENTS (8)

TRIAMCINOLONE ACETONIDEActive
Quantity: 5 mg in 1 g
Code: F446C597KA
Classification: ACTIB
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
ISOPROPYL PALMITATEInactive
Code: 8CRQ2TH63M
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
LACTIC ACID, UNSPECIFIED FORMInactive
Code: 33X04XA5AT
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

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Triamcinolone Acetonide - FDA Drug Approval Details