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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 084612

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NDA 084612 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, and Sandoz, and is included in ninety-two NDAs. It is available from forty-one suppliers. Additional details are available on the DEXAMETHASONE profile page.

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

Summary for 084612

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

Pharmacology for NDA: 084612

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 084612

Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents, Hormonal
Glucocorticoids

Suppliers and Packaging for NDA: 084612

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DEXAMETHASONE	dexamethasone	TABLET;ORAL	084612	ANDA	Hikma Pharmaceuticals USA, Inc.	0054-4179	0054-4179-25	100 TABLET in 1 BOTTLE, PLASTIC (0054-4179-25)
DEXAMETHASONE	dexamethasone	TABLET;ORAL	084612	ANDA	Hikma Pharmaceuticals USA, Inc.	0054-4180	0054-4180-25	100 TABLET in 1 BOTTLE, PLASTIC (0054-4180-25)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	4MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.5MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.75MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

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