Last Updated: November 8, 2026

Details for New Drug Application (NDA): 084020

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NDA 084020 describes TRIAMCINOLONE, which is a drug marketed by Barr, Impax Labs, Ivax Sub Teva Pharms, Mylan, Purepac Pharm, Roxane, Sandoz, Teva, Watson Labs, Actavis Mid Atlantic, Alkem Labs Ltd, Alpharma Us Pharms, Ambix, Chartwell Rx, Cosette Pharms Nc, Encube, Fougera Pharms, Glenmark Pharms Ltd, Macleods Pharms, Micro Labs, Morton Grove, Padagis Us, Pharmaderm, Pharmafair, Pharmobedient, Strides Pharma, Sun Pharma Canada, Taro, Topiderm, Alembic, Amneal, Caplin, Dr Reddys, Eugia Pharma, Hikma, Long Grove Pharms, Mylan Labs Ltd, Parnell, Teva Pharms Usa, Beach Prods, Epic Pharma Llc, Quagen, Aurobindo Pharma Ltd, Extrovis, Glenmark Speclt, Padagis Israel, Pharmazone, Rising, Sciegen Pharms, Apotex, and Perrigo Pharma Intl, and is included in one hundred and nineteen NDAs. Additional details are available on the TRIAMCINOLONE profile page.

The generic ingredient in TRIAMCINOLONE is triamcinolone diacetate. There are three drug master file entries for this compound. Additional details are available on the triamcinolone diacetate profile page.

Summary for 084020

Tradename:	TRIAMCINOLONE
Applicant:	Purepac Pharm
Ingredient:	triamcinolone
Patents:	0

Medical Subject Heading (MeSH) Categories for 084020

Anti-Inflammatory Agents
Glucocorticoids

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	2MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	4MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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