Last Updated: November 8, 2026

Details for New Drug Application (NDA): 085458

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NDA 085458 describes DEXAMETHASONE, which is a drug marketed by Alpharma Us Pharms, Chartwell Molecular, Pharmazone, Pharmobedient Cnsltg, Rising, Abraxis Pharm, Fresenius Kabi Usa, Hikma, Watson Labs, Alvogen, Amneal, Apotex, Bausch, Bionpharma, Chartwell Rx, Impax Labs, Key Therap, Novitium Pharma, Pangea, Pharmobedient, Phoenix Labs Ny, Prasco, Pvt Form, Roxane, Solgen, Sun Pharm Industries, Upsher Smith, Whiteworth Town Plsn, Zydus Lifesciences, Watson Labs Teva, Bel Mar, Dell Labs, Dr Reddys, Epic Pharma Llc, Eugia Pharma, Gland, Intl Medication, Luitpold, Lyphomed, Micro Labs, Mylan Labs Ltd, Quagen, 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 085458

Tradename:	DEXAMETHASONE
Applicant:	Watson Labs
Ingredient:	dexamethasone
Patents:	0

Medical Subject Heading (MeSH) Categories for 085458

Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents, Hormonal
Glucocorticoids

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	0.5MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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