Last Updated: May 10, 2026

Details for New Drug Application (NDA): 216295

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NDA 216295 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 Caplin, and is included in ninety-two NDAs. It is available from thirty-nine 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 216295

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

Pharmacology for NDA: 216295

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 216295

Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents, Hormonal
Glucocorticoids

Suppliers and Packaging for NDA: 216295

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DEXAMETHASONE	dexamethasone	TABLET;ORAL	216295	ANDA	Major Pharmaceuticals	0904-7444	0904-7444-61	100 BLISTER PACK in 1 CARTON (0904-7444-61) / 1 TABLET in 1 BLISTER PACK
DEXAMETHASONE	dexamethasone	TABLET;ORAL	216295	ANDA	Amneal Pharmaceuticals NY LLC	60219-2056	60219-2056-1	100 TABLET in 1 BOTTLE, PLASTIC (60219-2056-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2MG
Approval Date:	Sep 8, 2022	TE:	AB	RLD:	No

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