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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 216992

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NDA 216992 describes DEFLAZACORT, which is a drug marketed by Tris Pharma Inc, Upsher Smith Labs, Zydus Lifesciences, Aurobindo Pharma Ltd, and Sun Pharm, and is included in six NDAs. It is available from six suppliers. Additional details are available on the DEFLAZACORT profile page.

The generic ingredient in DEFLAZACORT is deflazacort. There are three drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the deflazacort profile page.

Summary for 216992

Tradename:	DEFLAZACORT
Applicant:	Upsher Smith Labs
Ingredient:	deflazacort
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;ORAL			Strength	22.75MG/ML
Approval Date:	Aug 11, 2025	TE:	AB	RLD:	No

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