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Last Updated: April 2, 2026

Details for New Drug Application (NDA): 217173


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NDA 217173 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 217173
Tradename:DEFLAZACORT
Applicant:Amneal
Ingredient:deflazacort
Patents:0
Pharmacology for NDA: 217173
Mechanism of ActionCorticosteroid Hormone Receptor Agonists
Suppliers and Packaging for NDA: 217173
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEFLAZACORT deflazacort TABLET;ORAL 217173 ANDA Amneal Pharmaceuticals NY LLC 60219-2282 60219-2282-1 1 BOTTLE in 1 CARTON (60219-2282-1) / 100 TABLET in 1 BOTTLE
DEFLAZACORT deflazacort TABLET;ORAL 217173 ANDA Amneal Pharmaceuticals NY LLC 60219-2283 60219-2283-1 1 BOTTLE in 1 CARTON (60219-2283-1) / 30 TABLET in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength6MG
Approval Date:Dec 12, 2025TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength18MG
Approval Date:Dec 12, 2025TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength30MG
Approval Date:Dec 12, 2025TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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