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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 084991

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NDA 084991 describes DEXONE 0.5, which is a drug marketed by Solvay and is included in one NDA. Additional details are available on the DEXONE 0.5 profile page.

The generic ingredient in DEXONE 0.5 is dexamethasone. There are thirty-nine drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the dexamethasone profile page.

Summary for 084991

Tradename:	DEXONE 0.5
Applicant:	Solvay
Ingredient:	dexamethasone
Patents:	0

Medical Subject Heading (MeSH) Categories for 084991

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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