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FLUVOXAMINE MALEATE 25 MG 100 TAB

Generic: Fluvoxamine maleate

NDC:62559-0158-01

Manufacturer:ANI Pharmaceuticals, Inc.

Strength:25 mg/1

Dosage Form:TABLET, COATED

Route:ORAL

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Drug Information

Identification

Generic Name

Fluvoxamine maleate

Brand Name

fluvoxamine maleate

Labeler / Distributor

ANI Pharmaceuticals, Inc.

Product Type

HUMAN PRESCRIPTION DRUG

Administration

Dosage Form

TABLET, COATED

Route of Administration

ORAL

FDA Application Number

NDA021519

Active Ingredients

Ingredient	Strength
FLUVOXAMINE MALEATE	25 mg/1

Pharmacological Class

Serotonin Reuptake InhibitorSerotonin Uptake Inhibitors [MoA]

Data sourced from openFDA / DailyMed. For full prescribing information, consult the drug label.

Wholesale compliance resources

DSCSA T2 documents DSCSA compliance resource hub

Drug Resources

Fluvoxamine maleate Drug Page NDC 62559-0158-01 Lookup

Clinical Drug Information

Indications & Usage

Use for relief of occasional sleeplessness caused by stress and repetitive thoughts

Warnings

Warnings When using this product keep away from eyes Stop use and ask a doctor if sleeplessness persists for more than two weeks: insomnia can be a symptom of serious underlying medical illness If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions adults: apply 2 sprays onto the tongue. Additional sprays may be taken during the night as needed. children under 12: ask a doctor

Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.