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QUETIAPINE 400 MG 1000 TAB

Generic: Quetiapine fumarate

NDC:47335-0907-18

Manufacturer:Sun Pharmaceutical Industries, Inc.

Strength:400 mg/1

Dosage Form:TABLET, FILM COATED

Route:ORAL

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Drug Information

Identification

Generic Name

Quetiapine fumarate

Brand Name

Quetiapine fumarate

Labeler / Distributor

Sun Pharmaceutical Industries, Inc.

Product Type

HUMAN PRESCRIPTION DRUG

Administration

Dosage Form

TABLET, FILM COATED

Route of Administration

ORAL

FDA Application Number

ANDA201190

Active Ingredients

Ingredient	Strength
QUETIAPINE FUMARATE	400 mg/1

Pharmacological Class

Atypical Antipsychotic

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

Quetiapine fumarate Drug Page NDC 47335-0907-18 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.