Trianex 0.05%
Trianex 0.05% (Triamcinolone Acetonide Ointment)
Approved
Approval ID
cde13809-a606-12ca-aece-f2ae594baa71
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 12, 2021
Manufacturers
FDA
Promius Pharma, LLC
DUNS: 020408265
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Triamcinolone Acetonide Ointment
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67857-806
Application NumberANDA089595
Product Classification
M
Marketing Category
C73584
G
Generic Name
Triamcinolone Acetonide Ointment
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 12, 2021
FDA Product Classification
INGREDIENTS (7)
TRIAMCINOLONE ACETONIDEActive
Quantity: 0.5 mg in 1 g
Code: F446C597KA
Classification: ACTIB
LIGHT MINERAL OILInactive
Code: N6K5787QVP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
CERESINInactive
Code: Q1LS2UJO3A
Classification: IACT
LANOLIN ALCOHOLSInactive
Code: 884C3FA9HE
Classification: IACT