FDA Product

Triamcinolone acetonide

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

Triamcinolone acetonide

FDA Product Code

53217-041

Regulatory Information

NDC Product Code

53217-041

Application Number

ANDA088042

Marketing Category

C73584

Effective Date

August 14, 2018

Territorial Authority

USA

FDA Title

Triamcinolone Acetonide

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

1

Company Information

ManufacturerAidarex Pharmaceuticals LLC

DUNS Number

801503249

Active Ingredients

TRIAMCINOLONE ACETONIDE

Quantity: 0.25 mg in 1 g

Code: F446C597KA

Class Code: ACTIB

MINERAL OIL

Code: T5L8T28FGP

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

SORBITOL

Code: 506T60A25R

Class Code: IACT

SORBIC ACID

Code: X045WJ989B

Class Code: IACT

POTASSIUM SORBATE

Code: 1VPU26JZZ4

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

CETYL PALMITATE

Code: 5ZA2S6B08X

Class Code: IACT

Active Moieties

TRIAMCINOLONE ACETONIDE

Code: F446C597KA

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