TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide Lotion, USP 0.025% and 0.1% For Topical Use Only Rx only
Approved
Approval ID
4c6ff738-60a3-4339-8e94-26fb9df65841
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 15, 2023
Manufacturers
FDA
QUAGEN PHARMACEUTICALS LLC
DUNS: 073645339
Products 2
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 Code70752-129
Application NumberANDA213559
Product Classification
M
Marketing Category
C73584
G
Generic Name
TRIAMCINOLONE ACETONIDE
Product Specifications
Route of AdministrationTOPICAL
Effective DateFebruary 15, 2023
FDA Product Classification
INGREDIENTS (10)
TRIAMCINOLONE ACETONIDEActive
Quantity: 0.25 mg in 1 mL
Code: F446C597KA
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
SORBITAN MONOPALMITATEInactive
Code: 77K6Z421KU
Classification: IACT
TRIAMCINOLONE ACETONIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70752-130
Application NumberANDA213559
Product Classification
M
Marketing Category
C73584
G
Generic Name
TRIAMCINOLONE ACETONIDE
Product Specifications
Route of AdministrationTOPICAL
Effective DateFebruary 15, 2023
FDA Product Classification
INGREDIENTS (10)
TRIAMCINOLONE ACETONIDEActive
Quantity: 1 mg in 1 mL
Code: F446C597KA
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SORBITAN MONOPALMITATEInactive
Code: 77K6Z421KU
Classification: IACT