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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Harvard Business School

Generated: February 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207058

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NDA 207058 describes DOFETILIDE, which is a drug marketed by Mayne Pharma Inc and is included in one NDA. It is available from one supplier. Additional details are available on the DOFETILIDE profile page.

The generic ingredient in DOFETILIDE is dofetilide. There are eleven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the dofetilide profile page.
Summary for 207058
Applicant:Mayne Pharma Inc
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 207058
Suppliers and Packaging for NDA: 207058
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOFETILIDE dofetilide CAPSULE;ORAL 207058 ANDA Mayne Pharma Inc. 51862-005 N 51862-005-60
DOFETILIDE dofetilide CAPSULE;ORAL 207058 ANDA Mayne Pharma Inc. 51862-025 N 51862-025-60

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.125MG
Approval Date:Jun 6, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.25MG
Approval Date:Jun 6, 2016TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.5MG
Approval Date:Jun 6, 2016TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Johnson and Johnson
Boehringer Ingelheim

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