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FLUVOXAMINE MALEATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: APPCO · Approved 2026-04-30

Drug application

FDA Application #
ANDA220328
Application type
Abbreviated New Drug Application (Generic)
Brand name
FLUVOXAMINE MALEATE
Generic name
Fluvoxamine Maleate
Active ingredients
FLUVOXAMINE MALEATE
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Marketing status
Prescription
Sponsor
APPCO
First approval
2026-04-30

Source

Authoritative
Drugs@FDA application overview
Machine
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