Last Updated: May 11, 2026

Details for New Drug Application (NDA): 212384

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NDA 212384 describes TRIAMCINOLONE ACETONIDE, which is a drug marketed by Actavis Mid Atlantic, Alkem Labs Ltd, Alpharma Us Pharms, Ambix, Chartwell Rx, Cosette, Encube, Fougera Pharms, Glenmark Pharms Ltd, Macleods Pharms Ltd, Micro Labs, Morton Grove, Norvium Bioscience, Padagis Us, Pharmaderm, Pharmafair, Strides Pharma, Sun Pharma Canada, Taro, Topiderm, Alembic, Amneal, Caplin, Dr Reddys, Eugia Pharma, Hikma, Long Grove Pharms, Mylan Labs Ltd, Parnell, Sandoz, Teva Pharms Usa, Watson Labs, Beach Prods, Epic Pharma Llc, Pai Holdings Pharm, Pharmobedient, Quagen, Aurobindo Pharma Ltd, Extrovis, Glenmark Speclt, Padagis Israel, Senores Pharms, Rising, Sciegen Pharms, Apotex, and Perrigo Pharma Intl, and is included in ninety-seven NDAs. It is available from seventy suppliers. Additional details are available on the TRIAMCINOLONE ACETONIDE profile page.

The generic ingredient in TRIAMCINOLONE ACETONIDE is triamcinolone acetonide. There are fifty-one drug master file entries for this compound. Eighty suppliers are listed for this compound. Additional details are available on the triamcinolone acetonide profile page.

Summary for 212384

Tradename:	TRIAMCINOLONE ACETONIDE
Applicant:	Encube
Ingredient:	triamcinolone acetonide
Patents:	0

Pharmacology for NDA: 212384

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 212384

Anti-Inflammatory Agents
Glucocorticoids
Immunosuppressive Agents

Suppliers and Packaging for NDA: 212384

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TRIAMCINOLONE ACETONIDE	triamcinolone acetonide	OINTMENT;TOPICAL	212384	ANDA	Encube Ethicals, Inc.	21922-024	21922-024-11	430 g in 1 JAR (21922-024-11)
TRIAMCINOLONE ACETONIDE	triamcinolone acetonide	OINTMENT;TOPICAL	212384	ANDA	Northstar Rx LLC	72603-319	72603-319-01	430 g in 1 JAR (72603-319-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	OINTMENT;TOPICAL			Strength	0.05%
Approval Date:	Nov 29, 2019	TE:	AT	RLD:	No

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