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FDA Approval

Triamcinolone Acetonide

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

FDA Approval Summary

Company
NorthStar Rx LLC
DUNS: 830546433
Effective Date
January 23, 2024
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Triamcinolone(400 mg in 10 mL)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Amneal Pharmaceuticals Private Limited

NorthStar Rx LLC

860156658

Products3

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 Code
16714-150
Application Number
ANDA207550
Marketing Category
ANDA (C73584)
Route of Administration
INTRA-ARTICULAR, INTRAMUSCULAR
Effective Date
January 23, 2024
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACT
TriamcinoloneActive
Code: F446C597KAClass: ACTIBQuantity: 400 mg in 10 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311Class: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT

Triamcinolone Acetonide

Product Details

NDC Product Code
16714-130
Application Number
ANDA207550
Marketing Category
ANDA (C73584)
Route of Administration
INTRA-ARTICULAR, INTRAMUSCULAR
Effective Date
January 23, 2024
TriamcinoloneActive
Code: F446C597KAClass: ACTIBQuantity: 40 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311Class: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT

Triamcinolone Acetonide

Product Details

NDC Product Code
16714-140
Application Number
ANDA207550
Marketing Category
ANDA (C73584)
Route of Administration
INTRA-ARTICULAR, INTRAMUSCULAR
Effective Date
January 23, 2024
TriamcinoloneActive
Code: F446C597KAClass: ACTIBQuantity: 200 mg in 5 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311Class: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
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