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Last Updated: July 13, 2024

Details for New Drug Application (NDA): 214650


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NDA 214650 describes DEFERASIROX, which is a drug marketed by Alkem Labs Ltd, Amneal, Annora Pharma, Aucta, Cipla, MSN, Mylan, Teva Pharms Usa, Actavis Elizabeth, Alembic, Bionpharma, Ichnos, Sun Pharm, Zydus Pharms, Aurobindo Pharma Ltd, Chartwell Rx, Piramal Hlthcare Uk, and Stevens J, and is included in thirty-one NDAs. It is available from nineteen suppliers. Additional details are available on the DEFERASIROX profile page.

The generic ingredient in DEFERASIROX is deferasirox. There are twenty drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the deferasirox profile page.
Summary for 214650
Tradename:DEFERASIROX
Applicant:Msn
Ingredient:deferasirox
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 214650
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEFERASIROX deferasirox GRANULE;ORAL 214650 ANDA MSN LABORATORIES PRIVATE LIMITED 69539-199 69539-199-30 30 PACKET in 1 CARTON (69539-199-30) / 1 GRANULE in 1 PACKET (69539-199-62)
DEFERASIROX deferasirox GRANULE;ORAL 214650 ANDA MSN LABORATORIES PRIVATE LIMITED 69539-200 69539-200-30 30 PACKET in 1 CARTON (69539-200-30) / 1 GRANULE in 1 PACKET (69539-200-62)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GRANULE;ORALStrength180MG
Approval Date:Mar 17, 2021TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:GRANULE;ORALStrength360MG
Approval Date:Mar 17, 2021TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:GRANULE;ORALStrength90MG
Approval Date:Apr 20, 2022TE:ABRLD:No

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