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Triamcinolone Acetonide

TRIAMCINOLONE ACETONIDE CREAM USP, 0.025%, 0.1%, 0.5%

Approved
Approval ID

063728a5-87b5-4b53-957a-d8e497fcf8b0

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 1, 2010

Manufacturers
FDA

Rebel Distributors Corp

DUNS: 118802834

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 Code21695-501
Application NumberANDA085692
Product Classification
M
Marketing Category
C73584
G
Generic Name
Triamcinolone Acetonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 16, 2007
FDA Product Classification

INGREDIENTS (9)

Cetyl AlcoholInactive
Code: 936JST6JCN
Classification: IACT
CERESINInactive
Code: Q1LS2UJO3A
Classification: IACT
Triamcinolone AcetonideActive
Quantity: 0.25 mg in 1 g
Code: F446C597KA
Classification: ACTIB
ISOPROPYL PALMITATEInactive
Code: 8CRQ2TH63M
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
GlycerinInactive
Code: PDC6A3C0OX
Classification: IACT
LACTIC ACIDInactive
Code: 33X04XA5AT
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Benzyl AlcoholInactive
Code: LKG8494WBH
Classification: IACT

Triamcinolone Acetonide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code21695-502
Application NumberANDA085692
Product Classification
M
Marketing Category
C73584
G
Generic Name
Triamcinolone Acetonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 16, 2007
FDA Product Classification

INGREDIENTS (9)

Triamcinolone AcetonideActive
Quantity: 5 mg in 1 g
Code: F446C597KA
Classification: ACTIB
CERESINInactive
Code: Q1LS2UJO3A
Classification: IACT
Cetyl AlcoholInactive
Code: 936JST6JCN
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
ISOPROPYL PALMITATEInactive
Code: 8CRQ2TH63M
Classification: IACT
GlycerinInactive
Code: PDC6A3C0OX
Classification: IACT
Benzyl AlcoholInactive
Code: LKG8494WBH
Classification: IACT
LACTIC ACIDInactive
Code: 33X04XA5AT
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT

Triamcinolone Acetonide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code21695-189
Application NumberANDA085692
Product Classification
M
Marketing Category
C73584
G
Generic Name
Triamcinolone Acetonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 16, 2007
FDA Product Classification

INGREDIENTS (9)

Triamcinolone AcetonideActive
Quantity: 1 mg in 1 g
Code: F446C597KA
Classification: ACTIB
ISOPROPYL PALMITATEInactive
Code: 8CRQ2TH63M
Classification: IACT
CERESINInactive
Code: Q1LS2UJO3A
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
Cetyl AlcoholInactive
Code: 936JST6JCN
Classification: IACT
GlycerinInactive
Code: PDC6A3C0OX
Classification: IACT
LACTIC ACIDInactive
Code: 33X04XA5AT
Classification: IACT
Benzyl AlcoholInactive
Code: LKG8494WBH
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT

Drug Labeling Information

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 4/13/2006

Rx only

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Triamcinolone Acetonide - FDA Drug Approval Details