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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 213543

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NDA 213543 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 213543

Tradename:	TRIAMCINOLONE ACETONIDE
Applicant:	Long Grove Pharms
Ingredient:	triamcinolone acetonide
Patents:	0

Pharmacology for NDA: 213543

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 213543

Anti-Inflammatory Agents
Glucocorticoids
Immunosuppressive Agents

Suppliers and Packaging for NDA: 213543

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TRIAMCINOLONE ACETONIDE	triamcinolone acetonide	INJECTABLE;INJECTION	213543	ANDA	Long Grove Pharmaceuticals, LLC	81298-5781	81298-5781-5	25 VIAL, SINGLE-USE in 1 CARTON (81298-5781-5) / 1 mL in 1 VIAL, SINGLE-USE (81298-5781-1)
TRIAMCINOLONE ACETONIDE	triamcinolone acetonide	INJECTABLE;INJECTION	213543	ANDA	Long Grove Pharmaceuticals, LLC	81298-5783	81298-5783-3	1 VIAL, MULTI-DOSE in 1 CARTON (81298-5783-3) / 10 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	40MG/ML
Approval Date:	Jan 19, 2022	TE:	AB	RLD:	No

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