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Last Updated: June 23, 2024

Details for New Drug Application (NDA): 207746


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NDA 207746 describes DOFETILIDE, which is a drug marketed by Accord Hlthcare, Bionpharma, Dr Reddys Labs Sa, Granules, MSN, Novast Labs, Prinston Inc, Rk Pharma, Sigmapharm Labs Llc, Strides Pharma, Sun Pharm, and Teva Pharms Usa, and is included in twelve NDAs. It is available from thirteen 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. Fifteen suppliers are listed for this compound. Additional details are available on the dofetilide profile page.
Summary for 207746
Tradename:DOFETILIDE
Applicant:Sigmapharm Labs Llc
Ingredient:dofetilide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 207746
Suppliers and Packaging for NDA: 207746
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOFETILIDE dofetilide CAPSULE;ORAL 207746 ANDA AvKARE 42291-411 42291-411-60 60 CAPSULE in 1 BOTTLE, PLASTIC (42291-411-60)
DOFETILIDE dofetilide CAPSULE;ORAL 207746 ANDA AvKARE 42291-412 42291-412-60 60 CAPSULE in 1 BOTTLE, PLASTIC (42291-412-60)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.125MG
Approval Date:Mar 26, 2018TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.25MG
Approval Date:Mar 26, 2018TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.5MG
Approval Date:Mar 26, 2018TE:ABRLD:No

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