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Last Updated: September 19, 2020

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Details for New Drug Application (NDA): 208519

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NDA 208519 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 208519
Tradename:DOFETILIDE
Applicant:Par Pharm Inc
Ingredient:dofetilide
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.125MG
Approval Date:Oct 9, 2018TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.25MG
Approval Date:Oct 9, 2018TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.5MG
Approval Date:Oct 9, 2018TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

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