Last Updated: September 24, 2026

Details for New Drug Application (NDA): 087385

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NDA 087385 describes TRIAMCINOLONE ACETONIDE, which is a drug marketed by 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, 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, 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-eight 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 is one drug master file entry for this compound. Eighty suppliers are listed for this compound. Additional details are available on the triamcinolone acetonide profile page.

Summary for 087385

Tradename:	TRIAMCINOLONE ACETONIDE
Applicant:	Padagis Us
Ingredient:	triamcinolone acetonide
Patents:	0

Pharmacology for NDA: 087385

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 087385

Anti-Inflammatory Agents
Glucocorticoids
Immunosuppressive Agents

Suppliers and Packaging for NDA: 087385

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TRIAMCINOLONE ACETONIDE	triamcinolone acetonide	OINTMENT;TOPICAL	087385	ANDA	Padagis Israel Pharmaceuticals Ltd	45802-049	45802-049-35	1 TUBE in 1 CARTON (45802-049-35) / 15 g in 1 TUBE
TRIAMCINOLONE ACETONIDE	triamcinolone acetonide	OINTMENT;TOPICAL	087385	ANDA	Padagis Israel Pharmaceuticals Ltd	45802-054	45802-054-05	454 g in 1 JAR (45802-054-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	OINTMENT;TOPICAL			Strength	0.5%
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AT	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	OINTMENT;TOPICAL			Strength	0.025%
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AT	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	OINTMENT;TOPICAL			Strength	0.1%
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AT	RLD:	Yes

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