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FDA Approval

KENALOG-10

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
October 27, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Triamcinolone(10 mg in 1 mL)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

KENALOG-10

Product Details

NDC Product Code
0003-0494
Application Number
NDA012041
Marketing Category
NDA (C73594)
Route of Administration
INTRA-ARTICULAR, INTRALESIONAL
Effective Date
October 30, 2017
sodium chlorideInactive
Code: 451W47IQ8XClass: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8HClass: IACT
nitrogenInactive
Code: N762921K75Class: IACT
Code: F446C597KAClass: ACTIBQuantity: 10 mg in 1 mL
benzyl alcoholInactive
Code: LKG8494WBHClass: IACT
sodium hydroxideInactive
Code: 55X04QC32IClass: IACT
hydrochloric acidInactive
Code: QTT17582CBClass: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMInactive
Code: K679OBS311Class: IACT
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