Last Updated: September 23, 2026

Details for New Drug Application (NDA): 088248

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NDA 088248 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 088248

Tradename:	DEXAMETHASONE
Applicant:	Hikma
Ingredient:	dexamethasone
Patents:	0

Pharmacology for NDA: 088248

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 088248

Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents, Hormonal
Glucocorticoids

Suppliers and Packaging for NDA: 088248

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DEXAMETHASONE	dexamethasone	SOLUTION;ORAL	088248	ANDA	Hikma Pharmaceuticals USA, Inc.	0054-3177	0054-3177-57	240 mL in 1 BOTTLE, PLASTIC (0054-3177-57)
DEXAMETHASONE	dexamethasone	SOLUTION;ORAL	088248	ANDA	Hikma Pharmaceuticals USA, Inc.	0054-3177	0054-3177-63	500 mL in 1 BOTTLE, PLASTIC (0054-3177-63)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	0.5MG/5ML
Approval Date:	Sep 1, 1983	TE:		RLD:	Yes

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