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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

Macleods Pharmaceuticals Limited

DUNS: 862128535

Effective Date

July 1, 2023

Labeling Type

Human Prescription Drug Label

Active Ingredients

Triamcinolone(5 mg in 1 g)

Manufacturing Establishments1

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

Labeler

Macleods Pharmaceuticals Limited

DUNS Number

860120472

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

33342-328

Application Number

ANDA209535

Marketing Category

ANDA (C73584)

Route of Administration

TOPICAL

Effective Date

July 1, 2023

Ingredients

TriamcinoloneActive

Code: F446C597KAClass: ACTIBQuantity: 5 mg in 1 g

CETYL ALCOHOLInactive

Code: 936JST6JCNClass: IACT

LACTIC ACIDInactive

Code: 33X04XA5ATClass: IACT

GLYCERINInactive

Code: PDC6A3C0OXClass: IACT

ISOPROPYL PALMITATEInactive

Code: 8CRQ2TH63MClass: IACT

SORBITOLInactive

Code: 506T60A25RClass: IACT

BENZYL ALCOHOLInactive

Code: LKG8494WBHClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

Triamcinolone Acetonide

Product Details

NDC Product Code

33342-329

Application Number

ANDA209535

Marketing Category

ANDA (C73584)

Route of Administration

TOPICAL

Effective Date

July 1, 2023

Ingredients

TriamcinoloneActive

Code: F446C597KAClass: ACTIBQuantity: 1 mg in 1 g

CETYL ALCOHOLInactive

Code: 936JST6JCNClass: IACT

GLYCERINInactive

Code: PDC6A3C0OXClass: IACT

ISOPROPYL PALMITATEInactive

Code: 8CRQ2TH63MClass: IACT

LACTIC ACIDInactive

Code: 33X04XA5ATClass: IACT

BENZYL ALCOHOLInactive

Code: LKG8494WBHClass: IACT

SORBITOLInactive

Code: 506T60A25RClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

Triamcinolone Acetonide

Product Details

NDC Product Code

33342-327

Application Number

ANDA209535

Marketing Category

ANDA (C73584)

Route of Administration

TOPICAL

Effective Date

July 1, 2023

Ingredients

CETYL ALCOHOLInactive

Code: 936JST6JCNClass: IACT

TriamcinoloneActive

Code: F446C597KAClass: ACTIBQuantity: 0.25 mg in 1 g

SORBITOLInactive

Code: 506T60A25RClass: IACT

ISOPROPYL PALMITATEInactive

Code: 8CRQ2TH63MClass: IACT

GLYCERINInactive

Code: PDC6A3C0OXClass: IACT

BENZYL ALCOHOLInactive

Code: LKG8494WBHClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

LACTIC ACIDInactive

Code: 33X04XA5ATClass: IACT

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Triamcinolone Acetonide - FDA Approval | MedPath