Last Updated: September 24, 2026

Details for New Drug Application (NDA): 088254

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NDA 088254 describes DEXAMETHASONE, which is a drug marketed by Alpharma Us Pharms, Chartwell Molecular, Kanchan Hlthcare, Pharmobedient Cnsltg, Rising, Abraxis Pharm, Fresenius Kabi Usa, Hikma, Watson Labs, Alvogen, Amneal, Apotex, Bausch, Bionpharma, Chartwell Rx, Corepharma, Impax Labs, Key Therap, Novitium Pharma, Pangea, Pharmobedient, Phoenix Labs Ny, Prasco, Pvt Form, Roxane, Sun Pharm Industries, Upsher Smith, Whiteworth Town Plsn, Zydus Lifesciences, Watson Labs Teva, Bel Mar, Dell Labs, Dr Reddys, Epic Pharma Llc, Eugia Pharma, Geneyork Pharms, Gland, Intl Medication, Luitpold, Lyphomed, Micro Labs, Mylan Labs Ltd, Somerset, Somerset Theraps Llc, Teva Parenteral, Wyeth Ayerst, Sola Barnes Hind, Bausch And Lomb Inc, and Caplin, and is included in ninety-two NDAs. It is available from forty suppliers. Additional details are available on the DEXAMETHASONE profile page.

The generic ingredient in DEXAMETHASONE is dexamethasone acetate. There are three drug master file entries for this compound. Additional details are available on the dexamethasone acetate profile page.

Summary for 088254

Tradename:	DEXAMETHASONE
Applicant:	Pharmobedient Cnsltg
Ingredient:	dexamethasone
Patents:	0

Medical Subject Heading (MeSH) Categories for 088254

Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents, Hormonal
Glucocorticoids

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	ELIXIR;ORAL			Strength	0.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jul 27, 1983	TE:		RLD:	Yes

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