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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 217813

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NDA 217813 describes DEFLAZACORT, which is a drug marketed by Sun Pharm Inds Inc, Tris Pharma Inc, Upsher Smith Labs, Zydus Lifesciences, Amneal, Aurobindo Pharma Ltd, and Sun Pharm, and is included in eight NDAs. It is available from seven 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. Ten suppliers are listed for this compound. Additional details are available on the deflazacort profile page.

Summary for 217813

Tradename:	DEFLAZACORT
Applicant:	Tris Pharma Inc
Ingredient:	deflazacort
Patents:	0

Pharmacology for NDA: 217813

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Suppliers and Packaging for NDA: 217813

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DEFLAZACORT	deflazacort	SUSPENSION;ORAL	217813	ANDA	Cranbury Pharmaceuticals, LLC	27808-249	27808-249-01	13 mL in 1 BOTTLE (27808-249-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;ORAL			Strength	22.75MG/ML
Approval Date:	Apr 25, 2024	TE:	AB	RLD:	No

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