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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 217123

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NDA 217123 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 217123

Tradename:	DEFLAZACORT
Applicant:	Aurobindo Pharma Ltd
Ingredient:	deflazacort
Patents:	0

Pharmacology for NDA: 217123

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Suppliers and Packaging for NDA: 217123

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DEFLAZACORT	deflazacort	TABLET;ORAL	217123	ANDA	Aurobindo Pharma Limited	59651-599	59651-599-01	100 TABLET in 1 BOTTLE (59651-599-01)
DEFLAZACORT	deflazacort	TABLET;ORAL	217123	ANDA	Aurobindo Pharma Limited	59651-600	59651-600-30	30 TABLET in 1 BOTTLE (59651-600-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	6MG
Approval Date:	Feb 9, 2024	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	18MG
Approval Date:	Feb 9, 2024	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	30MG
Approval Date:	Feb 9, 2024	TE:	AB	RLD:	No

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