MedPath

TRIDERM

TRIDERM (Triamcinolone Acetonide Cream USP), 0.025%, 0.1%, 0.5%

Approved
Approval ID

2c7fee2c-6f57-4de4-8803-98c0b31b07c3

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 24, 2023

Manufacturers
FDA

Crown Laboratories

DUNS: 079035945

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

NDC Product Code0316-0170
Application NumberANDA088042
Marketing CategoryC73584
Route of AdministrationTOPICAL
Effective DateOctober 24, 2023
Generic NameTriamcinolone Acetonide

INGREDIENTS (9)

TRIAMCINOLONE ACETONIDEActive
Quantity: 1 mg in 1 g
Code: F446C597KA
Classification: ACTIB
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
CETYL PALMITATEInactive
Code: 5ZA2S6B08X
Classification: IACT
SORBIC ACIDInactive
Code: X045WJ989B
Classification: IACT
POLAWAX POLYSORBATEInactive
Code: Q504PL8E0V
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Triamcinolone Acetonide

PRODUCT DETAILS

NDC Product Code0316-0175
Application NumberANDA088042
Marketing CategoryC73584
Route of AdministrationTOPICAL
Effective DateOctober 24, 2023
Generic NameTriamcinolone Acetonide

INGREDIENTS (9)

SORBITOLInactive
Code: 506T60A25R
Classification: IACT
TRIAMCINOLONE ACETONIDEActive
Quantity: 5 mg in 1 g
Code: F446C597KA
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4
Classification: IACT
CETYL PALMITATEInactive
Code: 5ZA2S6B08X
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SORBIC ACIDInactive
Code: X045WJ989B
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
POLAWAX POLYSORBATEInactive
Code: Q504PL8E0V
Classification: IACT

Triamcinolone Acetonide

PRODUCT DETAILS

NDC Product Code0316-0165
Application NumberANDA088042
Marketing CategoryC73584
Route of AdministrationTOPICAL
Effective DateOctober 24, 2023
Generic NameTriamcinolone Acetonide

INGREDIENTS (9)

PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SORBIC ACIDInactive
Code: X045WJ989B
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POLAWAX POLYSORBATEInactive
Code: Q504PL8E0V
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
CETYL PALMITATEInactive
Code: 5ZA2S6B08X
Classification: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4
Classification: IACT
TRIAMCINOLONE ACETONIDEActive
Quantity: 0.25 mg in 1 g
Code: F446C597KA
Classification: ACTIB
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
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