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Triamcinolone Acetonide

Triamcinolone Acetonide Cream USP, 0.025%, 0.1%, 0.5%

Approved
Approval ID

6a282425-8fdc-1fca-e053-2a91aa0a1c3a

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 16, 2021

Manufacturers
FDA

NuCare Pharmaceuticals,Inc.

DUNS: 010632300

Products 1

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 Code68071-4397
Application NumberANDA086413
Product Classification
M
Marketing Category
C73584
G
Generic Name
Triamcinolone Acetonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateFebruary 16, 2021
FDA Product Classification

INGREDIENTS (11)

PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SORBITAN MONOSTEARATEInactive
Code: NVZ4I0H58X
Classification: IACT
CETYL ESTERS WAXInactive
Code: D072FFP9GU
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
ISOPROPYL PALMITATEInactive
Code: 8CRQ2TH63M
Classification: IACT
POLYSORBATE 60Inactive
Code: CAL22UVI4M
Classification: IACT
SORBIC ACIDInactive
Code: X045WJ989B
Classification: IACT
TRIAMCINOLONE ACETONIDEActive
Quantity: 5 mg in 1 g
Code: F446C597KA
Classification: ACTIB

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Triamcinolone Acetonide - FDA Drug Approval Details