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DOFETILIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SIGMAPHARM LABS LLC · Approved 2018-03-26

Drug application

FDA Application #

ANDA207746

Application type

Abbreviated New Drug Application (Generic)

Brand name

DOFETILIDE

Generic name

DOFETILIDE

Active ingredients

DOFETILIDE

Dosage form

CAPSULE

Route

ORAL

Marketing status

Prescription

Sponsor

SIGMAPHARM LABS LLC

Manufacturer

Sigmapharm Laboratories, LLC

First approval

2018-03-26

Source

Authoritative

Drugs@FDA application overview

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