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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 217741


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NDA 217741 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 217741
Tradename:DEFLAZACORT
Applicant:Sun Pharm
Ingredient:deflazacort
Patents:0
Pharmacology for NDA: 217741
Suppliers and Packaging for NDA: 217741
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEFLAZACORT deflazacort TABLET;ORAL 217741 ANDA Sun Pharmaceutical Industries Limited 70095-040 70095-040-01 1 BOTTLE in 1 CARTON (70095-040-01) / 100 TABLET in 1 BOTTLE
DEFLAZACORT deflazacort TABLET;ORAL 217741 ANDA Sun Pharmaceutical Industries Limited 70095-041 70095-041-30 1 BOTTLE in 1 CARTON (70095-041-30) / 30 TABLET in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength6MG
Approval Date:Mar 18, 2025TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength18MG
Approval Date:Mar 18, 2025TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength30MG
Approval Date:Mar 18, 2025TE:ABRLD:No

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