Last Updated: September 28, 2026

Details for New Drug Application (NDA): 216992

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

The generic ingredient in DEFLAZACORT is deflazacort. There is one drug master file entry for this compound. Ten 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

Pharmacology for NDA: 216992

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Suppliers and Packaging for NDA: 216992

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DEFLAZACORT	deflazacort	SUSPENSION;ORAL	216992	ANDA	Upsher-Smith Laboratories, LLC	0245-0813	0245-0813-13	1 BOTTLE in 1 CARTON (0245-0813-13) / 13 mL in 1 BOTTLE

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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