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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 213619

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NDA 213619 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, Taro, Topiderm, Amneal, Eugia Pharma, Long Grove Pharms, Mylan Labs Ltd, Parnell, Sandoz, Teva Pharms Usa, Watson Labs, Epic Pharma Llc, Pai Holdings Pharm, Quagen, Wockhardt Bio Ag, Aurobindo Pharma Ltd, Cintex Svcs, Extrovis, Glenmark Speclt, Padagis Israel, Lyne, Sciegen Pharms Inc, Apotex, Perrigo Pharma Intl, and Rising, and is included in ninety-three NDAs. It is available from sixty-one 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-four suppliers are listed for this compound. Additional details are available on the triamcinolone acetonide profile page.

Summary for 213619

Tradename:	TRIAMCINOLONE ACETONIDE
Applicant:	Cintex Svcs
Ingredient:	triamcinolone acetonide
Patents:	0

Pharmacology for NDA: 213619

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 213619

Anti-Inflammatory Agents
Glucocorticoids
Immunosuppressive Agents

Suppliers and Packaging for NDA: 213619

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TRIAMCINOLONE ACETONIDE	triamcinolone acetonide	OINTMENT;TOPICAL	213619	ANDA	Cintex Services, LLC	24470-922	24470-922-15	430 g in 1 JAR (24470-922-15)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	OINTMENT;TOPICAL			Strength	0.05%
Approval Date:	Nov 10, 2020	TE:	AT	RLD:	No

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