Last Updated: July 27, 2026

Details for New Drug Application (NDA): 086413

✉ Email this page to a colleague

« Back to Dashboard

NDA 086413 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 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, Pharmobedient, Quagen, Aurobindo Pharma Ltd, Cosette, 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 sixty-nine 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-nine suppliers are listed for this compound. Additional details are available on the triamcinolone acetonide profile page.

Summary for 086413

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

Pharmacology for NDA: 086413

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 086413

Anti-Inflammatory Agents
Glucocorticoids
Immunosuppressive Agents

Suppliers and Packaging for NDA: 086413

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TRIAMCINOLONE ACETONIDE	triamcinolone acetonide	CREAM;TOPICAL	086413	ANDA	Padagis Israel Pharmaceuticals Ltd	45802-063	45802-063-05	454 g in 1 JAR (45802-063-05)
TRIAMCINOLONE ACETONIDE	triamcinolone acetonide	CREAM;TOPICAL	086413	ANDA	Padagis Israel Pharmaceuticals Ltd	45802-063	45802-063-35	1 TUBE in 1 CARTON (45802-063-35) / 15 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	0.5%
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AT	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	0.025%
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AT	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	0.1%
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AT	RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.