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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 220042

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NDA 220042 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 220042

Tradename:	DEFLAZACORT
Applicant:	Zydus Lifesciences
Ingredient:	deflazacort
Patents:	0

Pharmacology for NDA: 220042

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Suppliers and Packaging for NDA: 220042

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DEFLAZACORT	deflazacort	SUSPENSION;ORAL	220042	ANDA	Zydus Pharmaceuticals (USA) Inc.	70710-2007	70710-2007-3	1 BOTTLE in 1 CARTON (70710-2007-3) / 13 mL in 1 BOTTLE
DEFLAZACORT	deflazacort	SUSPENSION;ORAL	220042	ANDA	Zydus Pharmaceuticals (USA) Inc.	70710-2131	70710-2131-3	1 BOTTLE in 1 CARTON (70710-2131-3) / 13 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;ORAL			Strength	22.75MG/ML
Approval Date:	Oct 3, 2025	TE:	AB	RLD:	No

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