← FDA Drug Approvals (Drugs@FDA)

DOFETILIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: GRANULES · Approved 2021-10-14

Drug application

FDA Application #
ANDA212750
Application type
Abbreviated New Drug Application (Generic)
Brand name
DOFETILIDE
Generic name
DOFETILIDE 0.125MG
Active ingredients
DOFETILIDE
Dosage form
CAPSULE
Route
ORAL
Marketing status
Prescription
Sponsor
GRANULES
Manufacturer
Granules Pharmaceuticals Inc.
First approval
2021-10-14

Source

Authoritative
Drugs@FDA application overview
Machine
JSON-LD · Markdown