Last Updated: September 24, 2026

Details for New Drug Application (NDA): 084315

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NDA 084315 describes DEXAMETHASONE ACETATE, which is a drug marketed by Watson Labs and Watson Labs Teva and is included in two NDAs. Additional details are available on the DEXAMETHASONE ACETATE profile page.

The generic ingredient in DEXAMETHASONE ACETATE is dexamethasone acetate. There is one drug master file entry for this compound. Additional details are available on the dexamethasone acetate profile page.

Summary for 084315

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 8MG BASE/ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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