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FLUVOXAMINE MALEATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ANNORA PHARMA · Approved 2025-07-30

Drug application

FDA Application #

ANDA217024

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

ANNORA PHARMA

Manufacturer

Camber Pharmaceuticals, Inc.

First approval

2025-07-30

Source

Authoritative

Drugs@FDA application overview

Machine

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