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Last Updated: September 19, 2020

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Details for New Drug Application (NDA): 208625

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NDA 208625 describes DOFETILIDE, which is a drug marketed by Accord Hlthcare, Bionpharma Inc, Mayne Pharma Inc, MSN, Par Pharm Inc, Prinston Inc, Riconpharma Llc, Sigmapharm Labs Llc, and Sun Pharm, and is included in nine NDAs. It is available from nine suppliers. Additional details are available on the DOFETILIDE profile page.

The generic ingredient in DOFETILIDE is dofetilide. There are thirteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the dofetilide profile page.
Summary for 208625
Tradename:DOFETILIDE
Applicant:Bionpharma Inc
Ingredient:dofetilide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 208625
Suppliers and Packaging for NDA: 208625
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOFETILIDE dofetilide CAPSULE;ORAL 208625 ANDA Bionpharma Inc. 69452-131 69452-131-17 60 CAPSULE in 1 BOTTLE (69452-131-17)
DOFETILIDE dofetilide CAPSULE;ORAL 208625 ANDA Bionpharma Inc. 69452-132 69452-132-17 60 CAPSULE in 1 BOTTLE (69452-132-17)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.125MG
Approval Date:Apr 10, 2018TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.25MG
Approval Date:Apr 10, 2018TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.5MG
Approval Date:Apr 10, 2018TE:ABRLD:No

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