triamcinolone acetonide
TRIAMCINOLONE ACETONIDE CREAM USP, 0.025%, 0.1%, 0.5%
Approved
Approval ID
92a1ded0-8e1a-4994-9c8a-89e84fc85c94
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 1, 2018
Manufacturers
FDA
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
DUNS: 043838424
Products 3
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 Code0168-0002
Application NumberANDA085692
Product Classification
M
Marketing Category
C73584
G
Generic Name
triamcinolone acetonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateMarch 1, 2018
FDA Product Classification
INGREDIENTS (8)
Isopropyl PalmitateInactive
Code: 8CRQ2TH63M
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
triamcinolone acetonideActive
Quantity: 5 mg in 1 g
Code: F446C597KA
Classification: ACTIB
SorbitolInactive
Code: 506T60A25R
Classification: IACT
LACTIC ACID, UNSPECIFIED FORMInactive
Code: 33X04XA5AT
Classification: IACT
Cetyl AlcoholInactive
Code: 936JST6JCN
Classification: IACT
GlycerinInactive
Code: PDC6A3C0OX
Classification: IACT
Benzyl AlcoholInactive
Code: LKG8494WBH
Classification: IACT
triamcinolone acetonide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0168-0003
Application NumberANDA085692
Product Classification
M
Marketing Category
C73584
G
Generic Name
triamcinolone acetonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateMarch 1, 2018
FDA Product Classification
INGREDIENTS (8)
Isopropyl PalmitateInactive
Code: 8CRQ2TH63M
Classification: IACT
SorbitolInactive
Code: 506T60A25R
Classification: IACT
GlycerinInactive
Code: PDC6A3C0OX
Classification: IACT
LACTIC ACID, UNSPECIFIED FORMInactive
Code: 33X04XA5AT
Classification: IACT
triamcinolone acetonideActive
Quantity: 0.25 mg in 1 g
Code: F446C597KA
Classification: ACTIB
Cetyl AlcoholInactive
Code: 936JST6JCN
Classification: IACT
Benzyl AlcoholInactive
Code: LKG8494WBH
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
triamcinolone acetonide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0168-0004
Application NumberANDA085692
Product Classification
M
Marketing Category
C73584
G
Generic Name
triamcinolone acetonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateMarch 1, 2018
FDA Product Classification
INGREDIENTS (8)
triamcinolone acetonideActive
Quantity: 1 mg in 1 g
Code: F446C597KA
Classification: ACTIB
Cetyl AlcoholInactive
Code: 936JST6JCN
Classification: IACT
GlycerinInactive
Code: PDC6A3C0OX
Classification: IACT
Isopropyl PalmitateInactive
Code: 8CRQ2TH63M
Classification: IACT
SorbitolInactive
Code: 506T60A25R
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
LACTIC ACID, UNSPECIFIED FORMInactive
Code: 33X04XA5AT
Classification: IACT
Benzyl AlcoholInactive
Code: LKG8494WBH
Classification: IACT