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Last Updated: February 23, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203560


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NDA 203560 describes DEFERASIROX, which is a drug marketed by Actavis Elizabeth, Alembic Pharms Ltd, Alkem Labs Ltd, Bionpharma Inc, Ichnos, MSN, Sun Pharm, Amneal Pharms Co, Piramal Hlthcare Uk, Teva Pharms Usa, and Zydus Pharms, and is included in fifteen NDAs. It is available from fourteen 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. Fifteen suppliers are listed for this compound. Additional details are available on the deferasirox profile page.
Summary for 203560
Tradename:DEFERASIROX
Applicant:Actavis Elizabeth
Ingredient:deferasirox
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 203560
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEFERASIROX deferasirox TABLET, FOR SUSPENSION;ORAL 203560 ANDA Actavis Pharma, Inc. 45963-454 45963-454-30 30 TABLET, FOR SUSPENSION in 1 BOTTLE (45963-454-30)
DEFERASIROX deferasirox TABLET, FOR SUSPENSION;ORAL 203560 ANDA Actavis Pharma, Inc. 45963-455 45963-455-30 30 TABLET, FOR SUSPENSION in 1 BOTTLE (45963-455-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, FOR SUSPENSION;ORALStrength125MG
Approval Date:Jan 26, 2016TE:ABRLD:No
Regulatory Exclusivity Expiration:Apr 5, 2019
Regulatory Exclusivity Use:PATENT CHALLENGE

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, FOR SUSPENSION;ORALStrength250MG
Approval Date:Jan 26, 2016TE:ABRLD:No
Regulatory Exclusivity Expiration:Apr 5, 2019
Regulatory Exclusivity Use:PATENT CHALLENGE

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, FOR SUSPENSION;ORALStrength500MG
Approval Date:Jan 26, 2016TE:ABRLD:No
Regulatory Exclusivity Expiration:Apr 5, 2019
Regulatory Exclusivity Use:PATENT CHALLENGE

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