← FDA Drug Approvals (Drugs@FDA)

FLUVOXAMINE MALEATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ZYDUS PHARMS · Approved 2026-07-21

Drug application

FDA Application #

ANDA220447

Application type

Abbreviated New Drug Application (Generic)

Brand name

FLUVOXAMINE MALEATE

Generic name

FLUVOXAMINE MALEATE EXTENDED-RELEASE

Active ingredients

FLUVOXAMINE MALEATE

Dosage form

CAPSULE, EXTENDED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

ZYDUS PHARMS

Manufacturer

Zydus Pharmaceuticals USA Inc.

First approval

2026-07-21

Source

Authoritative

Drugs@FDA application overview

Machine

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