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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 040671

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NDA 040671 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, 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 Inc, Apotex, and Perrigo Pharma Intl, and is included in ninety-seven NDAs. It is available from sixty-eight 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. Seventy-eight suppliers are listed for this compound. Additional details are available on the triamcinolone acetonide profile page.

Summary for 040671

Tradename:	TRIAMCINOLONE ACETONIDE
Applicant:	Micro Labs
Ingredient:	triamcinolone acetonide
Patents:	0

Pharmacology for NDA: 040671

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 040671

Anti-Inflammatory Agents
Glucocorticoids
Immunosuppressive Agents

Suppliers and Packaging for NDA: 040671

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TRIAMCINOLONE ACETONIDE	triamcinolone acetonide	CREAM;TOPICAL	040671	ANDA	TruPharma, LLC	52817-811	52817-811-54	454 g in 1 JAR (52817-811-54)
TRIAMCINOLONE ACETONIDE	triamcinolone acetonide	CREAM;TOPICAL	040671	ANDA	Saptalis Pharmaceuticals, LLC.	71656-042	71656-042-15	1 TUBE in 1 CARTON (71656-042-15) / 15 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	0.025%
Approval Date:	Jun 9, 2006	TE:	AT	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	0.1%
Approval Date:	Jun 9, 2006	TE:	AT	RLD:	No

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